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Diastolic Dysfunction and Interstitial Lung Edema in Septic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03768752
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : February 4, 2019
Information provided by (Responsible Party):
Ursula Kahl, Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
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.

Condition or disease
Sepsis Diastolic Dysfunction Lung Edema Fluid Overload

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Left Ventricular Diastolic Dysfunction as a Risk Factor for Interstitial Lung Edema and General Edema in Septic Patients on the Intensive Care Unit
Actual Study Start Date : October 11, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Diastolic Dysfunction
Patients with pre-existing or new diastolic dysfunction.
Normal Diastolic Function
Patients with normal diastolic function.

Primary Outcome Measures :
  1. Diastolic Dysfunction [ Time Frame: While in septic condition, up to 10 days maximum. ]
    Diastolic Dysfunction specified by echocardiographic doppler derived mitral inflow pattern and tissue doppler derived diastolic mitral annular velocities (E/E').

  2. Pulmonary Edema [ Time Frame: While in septic condition, up to 10 days maximum. ]
    Pulmonary edema specified by B line ultrasound score (Lung ultrasound protocol for the assessment of pulmonary fluid status according to Enghardt et al. 2015).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients on the intensive care unit of the university hospital Hamburg-Eppendorf diagnosed with sepsis.

Inclusion Criteria:

  • Patients on the intensive care unit diagnosed with SIRS (systemic inflammatory response syndrome) or Sepsis.

Exclusion Criteria:

  • Patients with hemodynamically relevant cardiac defects.
  • Patients with mitral valve replacement.
  • Patients with pericardial effusion.
  • Patients with atrial fibrillation.
  • Patients with pacemaker therapy.
  • Patients with BMI > 35 kg/m2.
  • Patients with poor examination conditions for ultrasound.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03768752

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Contact: Ursula Kahl, MD +49 (0) 15222826227
Contact: Katharina Röher, MD

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Universitätskrankenhaus Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Silke Schrum, Dr.    +49 (0) 40 7410 - 54290   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
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Principal Investigator: Ursula Kahl, MD Klinik und Poliklinik für Anästhesie Universitätsklinikum Hamburg-Eppendorf

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Responsible Party: Ursula Kahl, Dr. med., Universitätsklinikum Hamburg-Eppendorf Identifier: NCT03768752    
Other Study ID Numbers: DD-Sepsis
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ursula Kahl, Universitätsklinikum Hamburg-Eppendorf:
intensive care unit
Additional relevant MeSH terms:
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Pulmonary Edema
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases