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Diastolic Dysfunction and Interstitial Lung Edema in Septic Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	30 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03768752
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Universitätsklinikum Hamburg-Eppendorf
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ursula Kahl, MD
Principal Investigator Affiliation	Klinik und Poliklinik für Anästhesie Universitätsklinikum Hamburg-Eppendorf
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Sepsis, Diastolic Dysfunction, Lung Edema, Fluid Overload

Arms & Interventions

Arms

: Diastolic Dysfunction

Patients with pre-existing or new diastolic dysfunction.

: Normal Diastolic Function

Patients with normal diastolic function.

Interventions

Contact a Trial Team

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