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Clinical Trials/NCT03768752
NCT03768752
Completed
N/A

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

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country83 target enrollmentOctober 11, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sepsis
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Enrollment
83
Locations
1
Primary Endpoint
Diastolic Dysfunction
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 11, 2018
End Date
May 3, 2019
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ursula Kahl

Dr. med.

Universitätsklinikum Hamburg-Eppendorf

Eligibility 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/m
  • Patients with poor examination conditions for ultrasound.

Outcomes

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).

Study Sites (1)

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