Diastolic Dysfunction and Interstitial Lung Edema in Septic Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03768752

Enrollment

Registered

2018-12-07

Start date

2018-10-11

Completion date

2019-05-03

Last updated

2021-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diastolic Dysfunction, Fluid Overload, Lung Edema, Sepsis

Keywords

intensive care unit, echocardiography

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

Germany

Outcome results