<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/NCT03243526</url>
  </required_header>
  <id_info>
    <org_study_id>N-42-2017</org_study_id>
    <nct_id>NCT03243526</nct_id>
  </id_info>
  <brief_title>Effect of Fluid Management Guided by Pulse Pressure Variation Vs Central Venous Pressure on Lung Water Assessed by Lung Ultrasound During Liver Transplantation</brief_title>
  <official_title>The Effect of Fluid Management Guided by Pulse Pressure Variation Versus Central Venous Pressure on Extra Vascular Lung Water Assessed by Lung Ultrasound Score During Liver Transplantation. A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      the aim in this study to assess the effect of fluid management in patient undergoing&#xD;
      orthotopic liver transplantation either by using pulse pressure variation or by central&#xD;
      venous pressure. we will assess the impact of fluid management by either methods on&#xD;
      oxygenation and extra vascular lung water visualized by lung ultrasound.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After induction of anesthesia lung ultrasound will be performed and arterial blood gases&#xD;
      (ABG) will be taken.&#xD;
&#xD;
      All patients in both groups will receive maintenance fluid in the form of crystalloids&#xD;
      (ringer acetate) 4 ml/kg/H. Then fluid boluses will be given according to each group:&#xD;
&#xD;
      Group c (cvp): will receive 250 ml albumin 5% boluses to maintain CVP around 5 cmH2o Group P&#xD;
      (ppv): will receive 250 ml albumin 5% boluses to maintain PPV below 13% as detected from&#xD;
      invasive blood pressure monitor.&#xD;
&#xD;
      For all patients in both groups: blood transfusion will be indicated with decreased HB% level&#xD;
      below 7 mg/dl in arterial blood gases. Other blood product (FFP, platelets and&#xD;
      cryoprecipitate) transfusion will be guided by lab results and clinical status of patient.&#xD;
      Plasma will be transfused if INR &gt; 1.5 and platelets will be transfused if count &lt; 50, 000&#xD;
&#xD;
      Lung ultrasound will be performed to diagnose EVLW. A Philips C5 ultrasound system (frequency&#xD;
      5Hz; Philips Medical Systems, Suresnes, France) with an ordinary echo probe will be used.&#xD;
      Chest ultrasound will be performed using the 12 regions method. Intercostals spaces on each&#xD;
      side will be examined anteriorly (midclavicular line), laterally (anterior axillary line) and&#xD;
      posteriorly (posterior axillary line) Four ultrasound aeration patterns a. Normal aeration&#xD;
      (N): 0 score ; line sliding sign associated with respiratory movement or less than 3 B lines&#xD;
      ; b. Moderate loss of lung aeration: score 1 ; a clear number of multiple visible B-lines&#xD;
      with horizontal spacing between adjacent B lines ≤ 7 mm (B7 lines) c. Severe loss of lung&#xD;
      aeration: score 2; multiple B lines fused together that were difficult to count with&#xD;
      horizontal spacing between adjacent B lines ≤ 3 mm (B3 lines); and d. Pulmonary&#xD;
      consolidation: score 3; hyperechoic lung tissue, accompanied by dynamic air bronchogram.&#xD;
&#xD;
      The final LUS of the patient was the sum of each regional ultrasound score (ranging from 0 to&#xD;
      36).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 20, 2017</start_date>
  <completion_date type="Actual">January 15, 2019</completion_date>
  <primary_completion_date type="Actual">January 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>two groups one recieve fluid guided by CVP and othe by PPV</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>patient will be blinded and person who will do lung ultrasound</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>lung ultrasound score</measure>
    <time_frame>5 minutes after surgical wound closure</time_frame>
    <description>lung score assessed by lung ultrasound to assess lung water. score range from 0 to 36</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>lung ultrasound score</measure>
    <time_frame>baseline 10 minutes after induction. and 1 hour after Intensive care admission</time_frame>
    <description>lung score assessed by lung ultrasound to assess lung water. score range from 0 to 36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>P/F ratio</measure>
    <time_frame>baseline 10 min after induction, 5 minutes after surgical wound closure and 1 hour after intensive care admission</time_frame>
    <description>ratio of Po2 to fraction of inspired oxygen.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Lung; Congestive</condition>
  <condition>Liver Transplantation</condition>
  <arm_group>
    <arm_group_label>Central venous pressure group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>fluid therapy to maintain CVP not 5 cmH2o</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pulse pressure variation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>fluid therapy will be guided by PPV to be less than 14%</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>fluid therapy</intervention_name>
    <description>fluid resuscitation guided by CVP or PPV</description>
    <arm_group_label>Central venous pressure group</arm_group_label>
    <arm_group_label>Pulse pressure variation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ASA physical status II- IV&#xD;
&#xD;
          2. Child C (end stage liver disease) ESLD patient.&#xD;
&#xD;
          3. Age (18- 70) years&#xD;
&#xD;
          4. Patients undergoing orthotopic liver transplantation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Parents' refusal.&#xD;
&#xD;
          2. Patients with chronic pulmonary disease ( Asthma, obstructive lung disease or&#xD;
             restrictive lung diseases)&#xD;
&#xD;
          3. Patient with impaired diastolic function more than grade I.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kasr Alainy Hospital , Faculty of Medicine</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Fallon MB, Abrams GA. Pulmonary dysfunction in chronic liver disease. Hepatology. 2000 Oct;32(4 Pt 1):859-65. doi: 10.1053/jhep.2000.7519. No abstract available.</citation>
    <PMID>11003635</PMID>
  </reference>
  <reference>
    <citation>Bozbas SS, Eyuboglu FO, Ozturk Ergur F, Gullu Arslan N, Sevmis S, Karakayali H, Haberal M. Pulmonary complications and mortality after liver transplant. Exp Clin Transplant. 2008 Dec;6(4):264-70.</citation>
    <PMID>19338487</PMID>
  </reference>
  <reference>
    <citation>Gardelli G, Feletti F, Nanni A, Mughetti M, Piraccini A, Zompatori M. Chest ultrasonography in the ICU. Respir Care. 2012 May;57(5):773-81. doi: 10.4187/respcare.01743.</citation>
    <PMID>22546298</PMID>
  </reference>
  <reference>
    <citation>Aghdashi M, Broofeh B, Mohammadi A. Diagnostic performances of high resolution trans-thoracic lung ultrasonography in pulmonary alveoli-interstitial involvement of rheumatoid lung disease. Int J Clin Exp Med. 2013 Aug 1;6(7):562-6. Print 2013.</citation>
    <PMID>23936595</PMID>
  </reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>June 14, 2019</last_update_submitted>
  <last_update_submitted_qc>June 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>Mohamed Elayashy Mohamed Ahmed Hassan</investigator_full_name>
    <investigator_title>clinical professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03243526
org study id: N-42-2017
nct id: NCT03243526
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
the aim in this study to assess the effect of fluid management in patient undergoing
      orthotopic liver transplantation either by using pulse pressure variation or by central
      venous pressure. we will assess the impact of fluid management by either methods on
      oxygenation and extra vascular lung water visualized by lung ultrasound.
After induction of anesthesia lung ultrasound will be performed and arterial blood gases
      (ABG) will be taken.

      All patients in both groups will receive maintenance fluid in the form of crystalloids
      (ringer acetate) 4 ml/kg/H. Then fluid boluses will be given according to each group:

      Group c (cvp): will receive 250 ml albumin 5% boluses to maintain CVP around 5 cmH2o Group P
      (ppv): will receive 250 ml albumin 5% boluses to maintain PPV below 13% as detected from
      invasive blood pressure monitor.

      For all patients in both groups: blood transfusion will be indicated with decreased HB% level
      below 7 mg/dl in arterial blood gases. Other blood product (FFP, platelets and
      cryoprecipitate) transfusion will be guided by lab results and clinical status of patient.
      Plasma will be transfused if INR > 1.5 and platelets will be transfused if count < 50, 000

      Lung ultrasound will be performed to diagnose EVLW. A Philips C5 ultrasound system (frequency
      5Hz; Philips Medical Systems, Suresnes, France) with an ordinary echo probe will be used.
      Chest ultrasound will be performed using the 12 regions method. Intercostals spaces on each
      side will be examined anteriorly (midclavicular line), laterally (anterior axillary line) and
      posteriorly (posterior axillary line) Four ultrasound aeration patterns a. Normal aeration
      (N): 0 score ; line sliding sign associated with respiratory movement or less than 3 B lines
      ; b. Moderate loss of lung aeration: score 1 ; a clear number of multiple visible B-lines
      with horizontal spacing between adjacent B lines ≤ 7 mm (B7 lines) c. Severe loss of lung
      aeration: score 2; multiple B lines fused together that were difficult to count with
      horizontal spacing between adjacent B lines ≤ 3 mm (B3 lines); and d. Pulmonary
      consolidation: score 3; hyperechoic lung tissue, accompanied by dynamic air bronchogram.

      The final LUS of the patient was the sum of each regional ultrasound score (ranging from 0 to
      36).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: two groups one recieve fluid guided by CVP and othe by PPV
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
masking description: patient will be blinded and person who will do lung ultrasound
measure: lung ultrasound score
time frame: 5 minutes after surgical wound closure
description: lung score assessed by lung ultrasound to assess lung water. score range from 0 to 36
measure: lung ultrasound score
time frame: baseline 10 minutes after induction. and 1 hour after Intensive care admission
description: lung score assessed by lung ultrasound to assess lung water. score range from 0 to 36
measure: P/F ratio
time frame: baseline 10 min after induction, 5 minutes after surgical wound closure and 1 hour after intensive care admission
description: ratio of Po2 to fraction of inspired oxygen.
arm group label: Central venous pressure group
arm group type: Placebo Comparator
description: fluid therapy to maintain CVP not 5 cmH2o
arm group label: Pulse pressure variation
arm group type: Experimental
description: fluid therapy will be guided by PPV to be less than 14%
intervention type: Other
intervention name: fluid therapy
description: fluid resuscitation guided by CVP or PPV
arm group label: Central venous pressure group
arm group label: Pulse pressure variation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Egypt
citation: Fallon MB, Abrams GA. Pulmonary dysfunction in chronic liver disease. Hepatology. 2000 Oct;32(4 Pt 1):859-65. doi: 10.1053/jhep.2000.7519. No abstract available.
PMID: 11003635
citation: Bozbas SS, Eyuboglu FO, Ozturk Ergur F, Gullu Arslan N, Sevmis S, Karakayali H, Haberal M. Pulmonary complications and mortality after liver transplant. Exp Clin Transplant. 2008 Dec;6(4):264-70.
PMID: 19338487
citation: Gardelli G, Feletti F, Nanni A, Mughetti M, Piraccini A, Zompatori M. Chest ultrasonography in the ICU. Respir Care. 2012 May;57(5):773-81. doi: 10.4187/respcare.01743.
PMID: 22546298
citation: Aghdashi M, Broofeh B, Mohammadi A. Diagnostic performances of high resolution trans-thoracic lung ultrasonography in pulmonary alveoli-interstitial involvement of rheumatoid lung disease. Int J Clin Exp Med. 2013 Aug 1;6(7):562-6. Print 2013.
PMID: 23936595
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: Mohamed Elayashy Mohamed Ahmed Hassan
investigator title: clinical professor
sharing ipd: Undecided