Diastolic Dysfunction and Interstitial Lung Edema in Septic Patients

May 11, 2021 updated by: Ursula Kahl, Universitätsklinikum Hamburg-Eppendorf

Left Ventricular Diastolic Dysfunction as a Risk Factor for Interstitial Lung Edema in Septic Patients on the Intensive Care Unit

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Universitätskrankenhaus Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients on the intensive care unit of the university hospital Hamburg-Eppendorf diagnosed with sepsis.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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').
While in septic condition, up to 10 days maximum.
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).
While in septic condition, up to 10 days maximum.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Ursula Kahl, MD, Klinik und Poliklinik für Anästhesie Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2018

Primary Completion (Actual)

May 3, 2019

Study Completion (Actual)

May 3, 2019

Study Registration Dates

First Submitted

November 30, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (Actual)

December 7, 2018

Study Record Updates

Last Update Posted (Actual)

May 14, 2021

Last Update Submitted That Met QC Criteria

May 11, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DD-Sepsis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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