NCT05640635

Inflammation During ECMO Therapy and ECMO Weaning

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this interventional clinical trial is to compare patients who undergo ECMO therapy for treatment of acute respiratory distress syndrome (ARDS) and a randomized into one of two possible weaning strategy groups. Group 1: Weaning from ventilator occurs before ECMO weaning. Group 2: Weaning from ECMO occurs before weaning from ventilator. This study investigates which one of these strategies is more indulgent for the lung, and leads to less inflammation and therefore less potential side effects and an overall more favourable clinical course. As a primary criterion, measure of IL-6 in blood samples will beused. As secondary criterions, SOFA score at various time points, ventilation pressures, lung injury score (LIS), length of stay in the intensive care unit, and ventilator-associated pneumonia as well as levels of inflammatory cells and cytokines in both blood samples and bronchoalveolar lavage at different time points will be determined.

Conditions

• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
PROCEDURE	Ventilator weaning first	Ventilator weaning initiated and completed before start of ECMO weaning.
PROCEDURE	ECMO weaning first	ECMO weaning initiated and completed before start of ventilator weaning.

Timeline

• Start date: 2023-01-01
• Primary completion: 2026-01-01
• Completion: 2026-12-01
• First posted: 2022-12-07
• Last updated: 2024-06-24

Locations

1 site across 1 country: Germany