<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01721928</url>
  </required_header>
  <id_info>
    <org_study_id>2012/942</org_study_id>
    <secondary_id>UiO</secondary_id>
    <nct_id>NCT01721928</nct_id>
  </id_info>
  <brief_title>Norwegian Intensive Care Unit Dalteparin Effect Study</brief_title>
  <acronym>NORIDES</acronym>
  <official_title>Norwegian Intensive Care Unit Dalteparin Effect Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of the NORIDES study is to investigate the effect of pharmacological&#xD;
      thromboprophylaxis with low molecular weight heparins (LMWHs) in critically ill patients, and&#xD;
      how it is affected by presence of acute kidney injury (AKI) and treatment with hemodialysis.&#xD;
      The main objective is to compare the prophylactic effect of dalteparin in intensive care unit&#xD;
      (ICU) patients with AKI and Citrate-Calcium dialysis (CiCa-dialysis) with a control group of&#xD;
      ICU patients with normal kidney function. Our main hypothesis is that CiCa-dialysis reduces&#xD;
      dalteparin effect, and that patients undergoing CiCa-dialysis do not achieve adequate&#xD;
      prophylaxis against venous thromboembolism (VTE). The primary endpoint is development of DVT&#xD;
      during ICU stay, the secondary endpoint inadequate heparin effect measured in blood samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Description of deep venous thrombosis (DVT) diagnosis: Screening for DVT using Doppler&#xD;
      Ultrasound (DUS) of both upper- and lower extremities will be performed within 48 hours after&#xD;
      ICU admission and thereafter twice a week until discharge from ICU or ICU stay equal to 30&#xD;
      days. An additional DUS will be performed 3 months after ICU discharge.&#xD;
&#xD;
      Description of heparin effect measured in blood samples: Blood samples will be drawn from&#xD;
      intravasal catheters (preferably arterial, alternatively central venous) to examine heparin&#xD;
      effect (anti-Xa activity, thrombin generation assay (TGA) and thrombelastography (TEG) and&#xD;
      other haematological analyses including antithrombin concentrations. Whole blood will be&#xD;
      drawn on two separate days (from minimum day 2 to maximum day 30 dependent on the dialysis&#xD;
      therapy) of ICU stay immediately before and 4 hours after dalteparin administration in order&#xD;
      to measure tough and peak effect of heparin. Dalteparin effect in ICU patients undergoing&#xD;
      dialysis therapy will be measured one day with and one day without ongoing dialysis therapy&#xD;
      in order to distinguish the effect of AKI from the effect of continuous renal replacement&#xD;
      therapy (CRRT).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2012</start_date>
  <completion_date type="Actual">March 1, 2017</completion_date>
  <primary_completion_date type="Actual">June 2, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The primary endpoint is development of deep venous thrombosis (DVT)</measure>
    <time_frame>Twice a week until ICU LOS 30 days or discharge from ICU</time_frame>
    <description>Screening for DVT using DUS of both upper- and lower extremities will be performed within 48 hours after ICU admission and thereafter twice a week until discharge from ICU or ICU stay equal to 30 days. An additional DUS will be performed 3 months after ICU discharge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The secondary endpoint is inadequate heparin effect measured in blood samples</measure>
    <time_frame>Blood samples is drawn 4 times during ICU stay, from minimum day 2 to maximum day 30 dependent on the dialysis therapy</time_frame>
    <description>Blood samples will be drawn from intravasal catheters (preferably arterial, alternatively central venous) to examine heparin effect (anti-Xa activity, TGA and TEG) and other haematological analyses including antithrombin concentrations. Whole blood will be drawn on two separate days immediately before and 4 hours after dalteparin administration in order to measure tough and peak effect of heparin. Dalteparin effect in ICU patients undergoing dialysis therapy will be measured one day with and one day without ongoing dialysis therapy in order to distinguish the effect of AKI from the effect of CRRT.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Which of the blood sample analyses anti-Xa activity, TEG or TGA is superior in detecting critically ill patients who will subsequently develop DVT?</measure>
    <time_frame>Whole blood will be drawn on two separate days from minimum day 2 to maximum day 30 dependent on the dialysis therapy, immediately before and 4 hours after dalteparin administration in order to measure tough and peak effect of heparin.</time_frame>
    <description>The blood sample analyses anti-Xa activity, TEG and TGA will be analysed, and their ability to detect critically ill patients who will subsequently develop DVT. Different patients with and without AKI will be compared. Samples from the same patients one day with and one day without dialysis therapy will also be compared.</description>
  </other_outcome>
  <other_outcome>
    <measure>Which factors affect heparin effect in critically ill patients?</measure>
    <time_frame>During ICU stay until LOS 30 days or discharge from ICU</time_frame>
    <description>The following factors will be assessed: Presence of AKI, dialysis therapy, Body mass index (BMI), gender, high severity of illness, use of vasopressors, presence of oedema and serum antithrombin concentrations.</description>
  </other_outcome>
  <other_outcome>
    <measure>What is the incidence of DVT and bleeding in ICU patients with and without CiCa-dialysis therapy, and is it correlated to heparin effect?</measure>
    <time_frame>During ICU stay until LOS 30 days or discharge from ICU</time_frame>
    <description>Compare the incidence of DVT and bleeding among ICU patients with and without CiCa-dialysis. Investigate if patient with bleeding have different anti-Xa activity levels, TGA and TEG than patients without bleeding, and if patients with DVT have different anti-Xa activity levels, TGA and TEG compared to patients without DVT.</description>
  </other_outcome>
  <other_outcome>
    <measure>Do ICU patients with AKI treated with CRRT have lower blood flow to the kidneys measured as renal perfusion index during contrast enhanced DUS compared to similar ICU patients without AKI?</measure>
    <time_frame>During ICU stay until LOS 30 days or discharge from ICU</time_frame>
    <description>Blood flow to the kidneys measured as renal perfusion index during contrast enhanced DUS will be compared in selected ICU patients with and without CRRT.</description>
  </other_outcome>
  <other_outcome>
    <measure>Is the renal blood flow measured as renal perfusion index during contrast enhanced DUS correlated to a global blood flow measured as cardiac index using PICCO®?</measure>
    <time_frame>During ICU stay until LOS 30 days or discharge from ICU</time_frame>
    <description>Blood flow to the kidneys measured as renal perfusion index during contrast enhanced DUS will be compared with global perfusion measured as cardiac index using a pulse contour analysis device (PICCO®).</description>
  </other_outcome>
  <other_outcome>
    <measure>Is examination of patient urine using Nuclear Magnetic Resonance (NMR) spectroscopy different in ICU patient with and without AKI and what is the effect of CiCa-dialysis on NMR spectroscopy?</measure>
    <time_frame>During ICU stay until LOS 30 days or discharge from ICU</time_frame>
    <description>NMR spectroscopy of urine in ICU patients with and without AKI necessitating CRRT will be compared, and levels in the same patients with and without dialysis therapy. Further, NMR spectroscopy of urine in the same patient with and without dialysis therapy will be compared.</description>
  </other_outcome>
  <other_outcome>
    <measure>Which bedside method is superior in predicting dialysis circuit clotting?</measure>
    <time_frame>During ICU stay until LOS 30 days or discharge from ICU</time_frame>
    <description>Collect data on filter clotting. Evaluate the predictive value of different bedside methods clinically used to forecast filter clotting: Post filter ionised calcium, heparin-active R-time during TEG, access pressure, filter pressure, return pressure and visual inspection of the dialysis circuit air trap.</description>
  </other_outcome>
  <other_outcome>
    <measure>Which factors affects filter lifetime during CiCa-dialysis?</measure>
    <time_frame>During ICU stay until LOS 30 days or discharge from ICU</time_frame>
    <description>Collect data on filter lifetime during CiCa-dialysis therapy and investigate if there is a correlation between measured filter lifetime and the following factors: Heparin effect, antithrombin levels, post filter ionised calcium, NMR spectroscopy of urine, clinical assessment of clotting as well as anatomical placement of the dialysis catheter.</description>
  </other_outcome>
  <other_outcome>
    <measure>Which risk factors for DVT are present in an ICU population and what is the contribution of each factor in development of DVT?</measure>
    <time_frame>During ICU stay until LOS 30 days or discharge from ICU</time_frame>
    <description>Prospective collection of data on risk factor for DVT in an ICU population according to international guidelines. Also screening for DVT in an ICU population using DUS. Thereafter we plan to perform an analysis on the contribution of each risk factor and combinations of risk factors on development of DVT, with special attention towards possible avoidable risk factors.</description>
  </other_outcome>
  <other_outcome>
    <measure>Is the presence of DVT in ICU patients influenced by the anatomical placement of catheters such as central venous catheters (CVCs) and dialysis catheters?</measure>
    <time_frame>During ICU stay until LOS 30 days or discharge from ICU</time_frame>
    <description>Compare the incidence of catheter related DVT if CVC and dialysis catheters are placed in the femoral, subclavian and internal jugular veins.</description>
  </other_outcome>
  <other_outcome>
    <measure>Does the presence of DVT influence the prognosis in ICU patients?</measure>
    <time_frame>Data will be collected during ICU stay until LOS 30 days or discharge from ICU. Mortality will also be assessed after ICU discharge.</time_frame>
    <description>To compare preset prognostic markers for morbidity (ICU and hospital length of stay in addition to time on ventilator and dialysis therapy) and mortality (ICU mortality and 30 days mortality) in patients with and without presence of DVT.</description>
  </other_outcome>
  <other_outcome>
    <measure>Does metabolic alkalosis due to CiCa-dialysis therapy lead to prolonged ventilator therapy?</measure>
    <time_frame>During ICU stay until LOS 30 days or discharge from ICU</time_frame>
    <description>To compare arterial blood gases in ICU patients with and without CiCa-dialysis and evaluate if patients treated with dialysis more often have metabolic alkalosis. Further, to study whether there is an association between presence of metabolic alkalosis and time spent on ventilator therapy.</description>
  </other_outcome>
  <other_outcome>
    <measure>What is the compliance to our clinical practice guidelines for thromboprophylaxis in the ICU, and does low compliance to guidelines lead to more frequent DVT?</measure>
    <time_frame>During ICU stay until LOS 30 days or discharge from ICU</time_frame>
    <description>To compare occurrence of DVT and its correlation to compliance to clinical practice guidelines for DVT prophylaxis, including pharmacological and non-pharmacological prophylaxis.</description>
  </other_outcome>
  <other_outcome>
    <measure>What is the occurrence of DVT 3 months after ICU discharge?</measure>
    <time_frame>Patients will be screened for DVT 3 months after ICU discharge.</time_frame>
    <description>To find the occurrence of DVT in critically ill patients 3 months after ICU discharge. Survivors who did not develop DVT during ICU stay will be screened for DVT after 3 months using DUS examination.</description>
  </other_outcome>
  <other_outcome>
    <measure>Future blood and urine analyses of ICU patients with and without AKI and dialysis therapy.</measure>
    <time_frame>Blood and urine samples will be collected during ICU stay until LOS 30 days or discharge from ICU. The samples will be stored for future analysis with a maximum of 10 years storage.</time_frame>
    <description>To compare blood and urine samples from critically ill patients with and without AKI and dialysis therapy. The blood and urin samples can be stored for maximum 10 years. The plan is to use new, yet not known analysis methods, and test their utility when assessing ICU patients with and without AKI and dialysis therapy.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">70</enrollment>
  <condition>Acute Kidney Injury</condition>
  <condition>Deep Venous Thrombosis</condition>
  <arm_group>
    <arm_group_label>ICU patients with AKI</arm_group_label>
    <description>ICU patients with AKI treated with continuous venovenous hemodialysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ICU patients without AKI</arm_group_label>
    <description>ICU patients without AKI defined as RIFLE group O and R</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous venovenous hemodialysis</intervention_name>
    <description>Continuous venovenous hemodialysis</description>
    <arm_group_label>ICU patients with AKI</arm_group_label>
    <other_name>CVVHD</other_name>
    <other_name>CRRT</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      12 ml whole blood (10 ml for storage and 2 ml for bedside TEG analysis) will be aspirated&#xD;
      from the arterial or the central venous catheter for each measurement. Four measurements will&#xD;
      be performed in each patient, from minimum day 2 to maximum day 30 dependent on the dialysis&#xD;
      therapy.&#xD;
&#xD;
      Four urinary samples (each of 20 ml) will be collected from urinary catheter collection bags&#xD;
      at the same time as blood samples are drawn.&#xD;
&#xD;
      Blood (20 mL stored as whole blood, serum and plasma) and urine samples (20 mL) will be&#xD;
      collected from each patient at the same time as blood samples are drawn. The samples will be&#xD;
      stored at - 70°C for future analysis.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The main objective is to compare the prophylactic effect of dalteparin in intensive care&#xD;
        unit patients with acute kidney injury and continuous renal replacement therapy with a&#xD;
        control group of intensive care unit patients with normal kidney function.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ICU patients receiving prophylactic dalteparin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Intraocular bleeding&#xD;
&#xD;
          -  Intracranial bleeding&#xD;
&#xD;
          -  Acute spinal cord lesion&#xD;
&#xD;
          -  Inherited coagulopathy&#xD;
&#xD;
          -  Ongoing, uncontrolled bleeding&#xD;
&#xD;
          -  Therapeutic anticoagulation&#xD;
&#xD;
          -  Uncorrected coagulopathy&#xD;
&#xD;
          -  Pregnancy or postpartum &lt; 6 weeks&#xD;
&#xD;
          -  Participation in an interventional study&#xD;
&#xD;
          -  RIFLE class E&#xD;
&#xD;
          -  Consent not received&#xD;
&#xD;
          -  ICU length of stay less than 48 hours&#xD;
&#xD;
          -  DVT detected at first DUS examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kjetil Sunde, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sigrid Beitland, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Per M Sandset, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0540</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
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  </reference>
  <reference>
    <citation>Van PY, Cho SD, Underwood SJ, Morris MS, Watters JM, Schreiber MA. Thrombelastography versus AntiFactor Xa levels in the assessment of prophylactic-dose enoxaparin in critically ill patients. J Trauma. 2009 Jun;66(6):1509-15; discussion 1515-7. doi: 10.1097/TA.0b013e3181a51e33.</citation>
    <PMID>19509608</PMID>
  </reference>
  <reference>
    <citation>Klein SM, Slaughter TF, Vail PT, Ginsberg B, El-Moalem HE, Alexander R, D'Ercole F, Greengrass RA, Perumal TT, Welsby I, Gan TJ. Thromboelastography as a perioperative measure of anticoagulation resulting from low molecular weight heparin: a comparison with anti-Xa concentrations. Anesth Analg. 2000 Nov;91(5):1091-5. doi: 10.1097/00000539-200011000-00009.</citation>
    <PMID>11049889</PMID>
  </reference>
  <reference>
    <citation>Schleyer AM, Schreuder AB, Jarman KM, Logerfo JP, Goss JR. Adherence to guideline-directed venous thromboembolism prophylaxis among medical and surgical inpatients at 33 academic medical centers in the United States. Am J Med Qual. 2011 May-Jun;26(3):174-80. doi: 10.1177/1062860610382289. Epub 2011 Apr 13.</citation>
    <PMID>21490270</PMID>
  </reference>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>December 11, 2017</last_update_submitted>
  <last_update_submitted_qc>December 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Sigrid Beitland</investigator_full_name>
    <investigator_title>Oslo University Hospital</investigator_title>
  </responsible_party>
  <keyword>Acute kidney injury</keyword>
  <keyword>Deep venous thrombosis</keyword>
  <keyword>Dialysis</keyword>
  <keyword>Prophylaxis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01721928
org study id: 2012/942
secondary id: UiO
nct id: NCT01721928
lead sponsor: 
collaborator: 
has dmc: No
The main purpose of the NORIDES study is to investigate the effect of pharmacological
      thromboprophylaxis with low molecular weight heparins (LMWHs) in critically ill patients, and
      how it is affected by presence of acute kidney injury (AKI) and treatment with hemodialysis.
      The main objective is to compare the prophylactic effect of dalteparin in intensive care unit
      (ICU) patients with AKI and Citrate-Calcium dialysis (CiCa-dialysis) with a control group of
      ICU patients with normal kidney function. Our main hypothesis is that CiCa-dialysis reduces
      dalteparin effect, and that patients undergoing CiCa-dialysis do not achieve adequate
      prophylaxis against venous thromboembolism (VTE). The primary endpoint is development of DVT
      during ICU stay, the secondary endpoint inadequate heparin effect measured in blood samples.
Description of deep venous thrombosis (DVT) diagnosis: Screening for DVT using Doppler
      Ultrasound (DUS) of both upper- and lower extremities will be performed within 48 hours after
      ICU admission and thereafter twice a week until discharge from ICU or ICU stay equal to 30
      days. An additional DUS will be performed 3 months after ICU discharge.

      Description of heparin effect measured in blood samples: Blood samples will be drawn from
      intravasal catheters (preferably arterial, alternatively central venous) to examine heparin
      effect (anti-Xa activity, thrombin generation assay (TGA) and thrombelastography (TEG) and
      other haematological analyses including antithrombin concentrations. Whole blood will be
      drawn on two separate days (from minimum day 2 to maximum day 30 dependent on the dialysis
      therapy) of ICU stay immediately before and 4 hours after dalteparin administration in order
      to measure tough and peak effect of heparin. Dalteparin effect in ICU patients undergoing
      dialysis therapy will be measured one day with and one day without ongoing dialysis therapy
      in order to distinguish the effect of AKI from the effect of continuous renal replacement
      therapy (CRRT).
observational model: Case-Control
time perspective: Prospective
measure: The primary endpoint is development of deep venous thrombosis (DVT)
time frame: Twice a week until ICU LOS 30 days or discharge from ICU
description: Screening for DVT using DUS of both upper- and lower extremities will be performed within 48 hours after ICU admission and thereafter twice a week until discharge from ICU or ICU stay equal to 30 days. An additional DUS will be performed 3 months after ICU discharge.
measure: The secondary endpoint is inadequate heparin effect measured in blood samples
time frame: Blood samples is drawn 4 times during ICU stay, from minimum day 2 to maximum day 30 dependent on the dialysis therapy
description: Blood samples will be drawn from intravasal catheters (preferably arterial, alternatively central venous) to examine heparin effect (anti-Xa activity, TGA and TEG) and other haematological analyses including antithrombin concentrations. Whole blood will be drawn on two separate days immediately before and 4 hours after dalteparin administration in order to measure tough and peak effect of heparin. Dalteparin effect in ICU patients undergoing dialysis therapy will be measured one day with and one day without ongoing dialysis therapy in order to distinguish the effect of AKI from the effect of CRRT.
measure: Which of the blood sample analyses anti-Xa activity, TEG or TGA is superior in detecting critically ill patients who will subsequently develop DVT?
time frame: Whole blood will be drawn on two separate days from minimum day 2 to maximum day 30 dependent on the dialysis therapy, immediately before and 4 hours after dalteparin administration in order to measure tough and peak effect of heparin.
description: The blood sample analyses anti-Xa activity, TEG and TGA will be analysed, and their ability to detect critically ill patients who will subsequently develop DVT. Different patients with and without AKI will be compared. Samples from the same patients one day with and one day without dialysis therapy will also be compared.
measure: Which factors affect heparin effect in critically ill patients?
time frame: During ICU stay until LOS 30 days or discharge from ICU
description: The following factors will be assessed: Presence of AKI, dialysis therapy, Body mass index (BMI), gender, high severity of illness, use of vasopressors, presence of oedema and serum antithrombin concentrations.
measure: What is the incidence of DVT and bleeding in ICU patients with and without CiCa-dialysis therapy, and is it correlated to heparin effect?
time frame: During ICU stay until LOS 30 days or discharge from ICU
description: Compare the incidence of DVT and bleeding among ICU patients with and without CiCa-dialysis. Investigate if patient with bleeding have different anti-Xa activity levels, TGA and TEG than patients without bleeding, and if patients with DVT have different anti-Xa activity levels, TGA and TEG compared to patients without DVT.
measure: Do ICU patients with AKI treated with CRRT have lower blood flow to the kidneys measured as renal perfusion index during contrast enhanced DUS compared to similar ICU patients without AKI?
time frame: During ICU stay until LOS 30 days or discharge from ICU
description: Blood flow to the kidneys measured as renal perfusion index during contrast enhanced DUS will be compared in selected ICU patients with and without CRRT.
measure: Is the renal blood flow measured as renal perfusion index during contrast enhanced DUS correlated to a global blood flow measured as cardiac index using PICCO®?
time frame: During ICU stay until LOS 30 days or discharge from ICU
description: Blood flow to the kidneys measured as renal perfusion index during contrast enhanced DUS will be compared with global perfusion measured as cardiac index using a pulse contour analysis device (PICCO®).
measure: Is examination of patient urine using Nuclear Magnetic Resonance (NMR) spectroscopy different in ICU patient with and without AKI and what is the effect of CiCa-dialysis on NMR spectroscopy?
time frame: During ICU stay until LOS 30 days or discharge from ICU
description: NMR spectroscopy of urine in ICU patients with and without AKI necessitating CRRT will be compared, and levels in the same patients with and without dialysis therapy. Further, NMR spectroscopy of urine in the same patient with and without dialysis therapy will be compared.
measure: Which bedside method is superior in predicting dialysis circuit clotting?
time frame: During ICU stay until LOS 30 days or discharge from ICU
description: Collect data on filter clotting. Evaluate the predictive value of different bedside methods clinically used to forecast filter clotting: Post filter ionised calcium, heparin-active R-time during TEG, access pressure, filter pressure, return pressure and visual inspection of the dialysis circuit air trap.
measure: Which factors affects filter lifetime during CiCa-dialysis?
time frame: During ICU stay until LOS 30 days or discharge from ICU
description: Collect data on filter lifetime during CiCa-dialysis therapy and investigate if there is a correlation between measured filter lifetime and the following factors: Heparin effect, antithrombin levels, post filter ionised calcium, NMR spectroscopy of urine, clinical assessment of clotting as well as anatomical placement of the dialysis catheter.
measure: Which risk factors for DVT are present in an ICU population and what is the contribution of each factor in development of DVT?
time frame: During ICU stay until LOS 30 days or discharge from ICU
description: Prospective collection of data on risk factor for DVT in an ICU population according to international guidelines. Also screening for DVT in an ICU population using DUS. Thereafter we plan to perform an analysis on the contribution of each risk factor and combinations of risk factors on development of DVT, with special attention towards possible avoidable risk factors.
measure: Is the presence of DVT in ICU patients influenced by the anatomical placement of catheters such as central venous catheters (CVCs) and dialysis catheters?
time frame: During ICU stay until LOS 30 days or discharge from ICU
description: Compare the incidence of catheter related DVT if CVC and dialysis catheters are placed in the femoral, subclavian and internal jugular veins.
measure: Does the presence of DVT influence the prognosis in ICU patients?
time frame: Data will be collected during ICU stay until LOS 30 days or discharge from ICU. Mortality will also be assessed after ICU discharge.
description: To compare preset prognostic markers for morbidity (ICU and hospital length of stay in addition to time on ventilator and dialysis therapy) and mortality (ICU mortality and 30 days mortality) in patients with and without presence of DVT.
measure: Does metabolic alkalosis due to CiCa-dialysis therapy lead to prolonged ventilator therapy?
time frame: During ICU stay until LOS 30 days or discharge from ICU
description: To compare arterial blood gases in ICU patients with and without CiCa-dialysis and evaluate if patients treated with dialysis more often have metabolic alkalosis. Further, to study whether there is an association between presence of metabolic alkalosis and time spent on ventilator therapy.
measure: What is the compliance to our clinical practice guidelines for thromboprophylaxis in the ICU, and does low compliance to guidelines lead to more frequent DVT?
time frame: During ICU stay until LOS 30 days or discharge from ICU
description: To compare occurrence of DVT and its correlation to compliance to clinical practice guidelines for DVT prophylaxis, including pharmacological and non-pharmacological prophylaxis.
measure: What is the occurrence of DVT 3 months after ICU discharge?
time frame: Patients will be screened for DVT 3 months after ICU discharge.
description: To find the occurrence of DVT in critically ill patients 3 months after ICU discharge. Survivors who did not develop DVT during ICU stay will be screened for DVT after 3 months using DUS examination.
measure: Future blood and urine analyses of ICU patients with and without AKI and dialysis therapy.
time frame: Blood and urine samples will be collected during ICU stay until LOS 30 days or discharge from ICU. The samples will be stored for future analysis with a maximum of 10 years storage.
description: To compare blood and urine samples from critically ill patients with and without AKI and dialysis therapy. The blood and urin samples can be stored for maximum 10 years. The plan is to use new, yet not known analysis methods, and test their utility when assessing ICU patients with and without AKI and dialysis therapy.
arm group label: ICU patients with AKI
description: ICU patients with AKI treated with continuous venovenous hemodialysis
arm group label: ICU patients without AKI
description: ICU patients without AKI defined as RIFLE group O and R
intervention type: Device
intervention name: Continuous venovenous hemodialysis
description: Continuous venovenous hemodialysis
arm group label: ICU patients with AKI
other name: CVVHD
other name: CRRT
12 ml whole blood (10 ml for storage and 2 ml for bedside TEG analysis) will be aspirated
      from the arterial or the central venous catheter for each measurement. Four measurements will
      be performed in each patient, from minimum day 2 to maximum day 30 dependent on the dialysis
      therapy.

      Four urinary samples (each of 20 ml) will be collected from urinary catheter collection bags
      at the same time as blood samples are drawn.

      Blood (20 mL stored as whole blood, serum and plasma) and urine samples (20 mL) will be
      collected from each patient at the same time as blood samples are drawn. The samples will be
      stored at - 70°C for future analysis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kjetil Sunde, Professor
role: Study Chair
affiliation: Oslo University Hospital
last name: Sigrid Beitland, MD
role: Principal Investigator
affiliation: Oslo University Hospital
last name: Per M Sandset, Professor
role: Study Director
affiliation: Oslo University Hospital
facility: 
country: Norway
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PMID: 16552665
citation: Cook DJ, Douketis J, Arnold D, Crowther MA. Bleeding and venous thromboembolism in the critically ill with emphasis on patients with renal insufficiency. Curr Opin Pulm Med. 2009 Sep;15(5):455-62. doi: 10.1097/MCP.0b013e32832ea4dd.
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PMID: 19509608
citation: Klein SM, Slaughter TF, Vail PT, Ginsberg B, El-Moalem HE, Alexander R, D'Ercole F, Greengrass RA, Perumal TT, Welsby I, Gan TJ. Thromboelastography as a perioperative measure of anticoagulation resulting from low molecular weight heparin: a comparison with anti-Xa concentrations. Anesth Analg. 2000 Nov;91(5):1091-5. doi: 10.1097/00000539-200011000-00009.
PMID: 11049889
citation: Schleyer AM, Schreuder AB, Jarman KM, Logerfo JP, Goss JR. Adherence to guideline-directed venous thromboembolism prophylaxis among medical and surgical inpatients at 33 academic medical centers in the United States. Am J Med Qual. 2011 May-Jun;26(3):174-80. doi: 10.1177/1062860610382289. Epub 2011 Apr 13.
PMID: 21490270
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Sigrid Beitland
investigator title: Oslo University Hospital
mesh term: Acute Kidney Injury
mesh term: Thrombosis
mesh term: Venous Thrombosis