<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/NCT03768752</url>
  </required_header>
  <id_info>
    <org_study_id>DD-Sepsis</org_study_id>
    <nct_id>NCT03768752</nct_id>
  </id_info>
  <brief_title>Diastolic Dysfunction and Interstitial Lung Edema in Septic Patients</brief_title>
  <official_title>Left Ventricular Diastolic Dysfunction as a Risk Factor for Interstitial Lung Edema in Septic Patients on the Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</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>
      Sepsis is one of the most challenging conditions with an exceptionally high mortality rate.&#xD;
      Diastolic Dysfunction is common in septic patients and has been found to be associated with&#xD;
      mortality. However, the reasons for this remain unclear. Therefore, the goal of this study is&#xD;
      to investigate diastolic dysfunction in septic patients on the intensive care unit. Special&#xD;
      attention is paid to the presence of lung edema and general edema as a potential link between&#xD;
      diastolic dysfunction and elevated mortality in septic patients. During the septic phase&#xD;
      daily ultrasound examinations of heart and lung will be performed as to monitor diastolic&#xD;
      function and lung edema.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2018</start_date>
  <completion_date type="Actual">May 3, 2019</completion_date>
  <primary_completion_date type="Actual">May 3, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diastolic Dysfunction</measure>
    <time_frame>While in septic condition, up to 10 days maximum.</time_frame>
    <description>Diastolic Dysfunction specified by echocardiographic doppler derived mitral inflow pattern and tissue doppler derived diastolic mitral annular velocities (E/E').</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulmonary Edema</measure>
    <time_frame>While in septic condition, up to 10 days maximum.</time_frame>
    <description>Pulmonary edema specified by B line ultrasound score (Lung ultrasound protocol for the assessment of pulmonary fluid status according to Enghardt et al. 2015).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">83</enrollment>
  <condition>Sepsis</condition>
  <condition>Diastolic Dysfunction</condition>
  <condition>Lung Edema</condition>
  <condition>Fluid Overload</condition>
  <arm_group>
    <arm_group_label>Diastolic Dysfunction</arm_group_label>
    <description>Patients with pre-existing or new diastolic dysfunction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Diastolic Function</arm_group_label>
    <description>Patients with normal diastolic function.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients on the intensive care unit of the university hospital Hamburg-Eppendorf diagnosed&#xD;
        with sepsis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients on the intensive care unit diagnosed with SIRS (systemic inflammatory&#xD;
             response syndrome) or Sepsis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with hemodynamically relevant cardiac defects.&#xD;
&#xD;
          -  Patients with mitral valve replacement.&#xD;
&#xD;
          -  Patients with pericardial effusion.&#xD;
&#xD;
          -  Patients with atrial fibrillation.&#xD;
&#xD;
          -  Patients with pacemaker therapy.&#xD;
&#xD;
          -  Patients with BMI &gt; 35 kg/m2.&#xD;
&#xD;
          -  Patients with poor examination conditions for ultrasound.&#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>Ursula Kahl, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik und Poliklinik für Anästhesie Universitätsklinikum Hamburg-Eppendorf</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätskrankenhaus Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Fleischmann C, Scherag A, Adhikari NK, Hartog CS, Tsaganos T, Schlattmann P, Angus DC, Reinhart K; International Forum of Acute Care Trialists. Assessment of Global Incidence and Mortality of Hospital-treated Sepsis. Current Estimates and Limitations. Am J Respir Crit Care Med. 2016 Feb 1;193(3):259-72. doi: 10.1164/rccm.201504-0781OC.</citation>
    <PMID>26414292</PMID>
  </reference>
  <reference>
    <citation>Martin GS, Mannino DM, Eaton S, Moss M. The epidemiology of sepsis in the United States from 1979 through 2000. N Engl J Med. 2003 Apr 17;348(16):1546-54. doi: 10.1056/NEJMoa022139.</citation>
    <PMID>12700374</PMID>
  </reference>
  <reference>
    <citation>Sanfilippo F, Corredor C, Fletcher N, Landesberg G, Benedetto U, Foex P, Cecconi M. Diastolic dysfunction and mortality in septic patients: a systematic review and meta-analysis. Intensive Care Med. 2015 Jun;41(6):1004-13. doi: 10.1007/s00134-015-3748-7. Epub 2015 Mar 24. Erratum In: Intensive Care Med. 2015 Jun;41(6):1178-9.</citation>
    <PMID>25800584</PMID>
  </reference>
  <reference>
    <citation>Enghard P, Rademacher S, Nee J, Hasper D, Engert U, Jorres A, Kruse JM. Simplified lung ultrasound protocol shows excellent prediction of extravascular lung water in ventilated intensive care patients. Crit Care. 2015 Feb 6;19(1):36. doi: 10.1186/s13054-015-0756-5.</citation>
    <PMID>25656060</PMID>
  </reference>
  <reference>
    <citation>Suehiro K, Morikage N, Murakami M, Yamashita O, Samura M, Hamano K. Significance of ultrasound examination of skin and subcutaneous tissue in secondary lower extremity lymphedema. Ann Vasc Dis. 2013;6(2):180-8. doi: 10.3400/avd.oa.12.00102. Epub 2013 May 10.</citation>
    <PMID>23825499</PMID>
  </reference>
  <reference>
    <citation>Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.</citation>
    <PMID>8844239</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>May 11, 2021</last_update_submitted>
  <last_update_submitted_qc>May 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitätsklinikum Hamburg-Eppendorf</investigator_affiliation>
    <investigator_full_name>Ursula Kahl</investigator_full_name>
    <investigator_title>Dr. med.</investigator_title>
  </responsible_party>
  <keyword>intensive care unit</keyword>
  <keyword>echocardiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Edema</mesh_term>
    <mesh_term>Edema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03768752
org study id: DD-Sepsis
nct id: NCT03768752
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sepsis is one of the most challenging conditions with an exceptionally high mortality rate.
      Diastolic Dysfunction is common in septic patients and has been found to be associated with
      mortality. However, the reasons for this remain unclear. Therefore, the goal of this study is
      to investigate diastolic dysfunction in septic patients on the intensive care unit. Special
      attention is paid to the presence of lung edema and general edema as a potential link between
      diastolic dysfunction and elevated mortality in septic patients. During the septic phase
      daily ultrasound examinations of heart and lung will be performed as to monitor diastolic
      function and lung edema.
observational model: Cohort
time perspective: Prospective
measure: Diastolic Dysfunction
time frame: While in septic condition, up to 10 days maximum.
description: Diastolic Dysfunction specified by echocardiographic doppler derived mitral inflow pattern and tissue doppler derived diastolic mitral annular velocities (E/E').
measure: Pulmonary Edema
time frame: While in septic condition, up to 10 days maximum.
description: Pulmonary edema specified by B line ultrasound score (Lung ultrasound protocol for the assessment of pulmonary fluid status according to Enghardt et al. 2015).
arm group label: Diastolic Dysfunction
description: Patients with pre-existing or new diastolic dysfunction.
arm group label: Normal Diastolic Function
description: Patients with normal diastolic function.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ursula Kahl, MD
role: Principal Investigator
affiliation: Klinik und Poliklinik für Anästhesie Universitätsklinikum Hamburg-Eppendorf
facility: 
country: Germany
citation: Fleischmann C, Scherag A, Adhikari NK, Hartog CS, Tsaganos T, Schlattmann P, Angus DC, Reinhart K; International Forum of Acute Care Trialists. Assessment of Global Incidence and Mortality of Hospital-treated Sepsis. Current Estimates and Limitations. Am J Respir Crit Care Med. 2016 Feb 1;193(3):259-72. doi: 10.1164/rccm.201504-0781OC.
PMID: 26414292
citation: Martin GS, Mannino DM, Eaton S, Moss M. The epidemiology of sepsis in the United States from 1979 through 2000. N Engl J Med. 2003 Apr 17;348(16):1546-54. doi: 10.1056/NEJMoa022139.
PMID: 12700374
citation: Sanfilippo F, Corredor C, Fletcher N, Landesberg G, Benedetto U, Foex P, Cecconi M. Diastolic dysfunction and mortality in septic patients: a systematic review and meta-analysis. Intensive Care Med. 2015 Jun;41(6):1004-13. doi: 10.1007/s00134-015-3748-7. Epub 2015 Mar 24. Erratum In: Intensive Care Med. 2015 Jun;41(6):1178-9.
PMID: 25800584
citation: Enghard P, Rademacher S, Nee J, Hasper D, Engert U, Jorres A, Kruse JM. Simplified lung ultrasound protocol shows excellent prediction of extravascular lung water in ventilated intensive care patients. Crit Care. 2015 Feb 6;19(1):36. doi: 10.1186/s13054-015-0756-5.
PMID: 25656060
citation: Suehiro K, Morikage N, Murakami M, Yamashita O, Samura M, Hamano K. Significance of ultrasound examination of skin and subcutaneous tissue in secondary lower extremity lymphedema. Ann Vasc Dis. 2013;6(2):180-8. doi: 10.3400/avd.oa.12.00102. Epub 2013 May 10.
PMID: 23825499
citation: Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.
PMID: 8844239
responsible party type: Principal Investigator
investigator affiliation: Universitätsklinikum Hamburg-Eppendorf
investigator full name: Ursula Kahl
investigator title: Dr. med.
mesh term: Pulmonary Edema
mesh term: Edema
sharing ipd: No