Diastolic Dysfunction and Interstitial Lung Edema in Septic Patients

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.

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Key information

Conditions

Sepsis Diastolic Dysfunction Edema Fluid Overload Infections Inflammation Lung Diseases Lung Edema Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Edema Respiratory Tract Diseases Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätskrankenhaus Hamburg-Eppendorf

Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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').
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).

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Dec 7, 2018
Registry last updated: May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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