Diastolic Dysfunction and Interstitial Lung Edema in Septic Patients

Completed

• Conditions: Sepsis; Lung Edema; Fluid Overload; Diastolic Dysfunction

• Registration Number: NCT03768752
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-11
• Study First Submitted: 2018-11-30
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-07
• Primary Completion: 2019-05-03
• Study Completion: 2019-05-03
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-11
• Last Update Posted: 2021-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diastolic Dysfunction	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	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).

Trial Locations

Locations (1)

Universitätskrankenhaus Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany