NCT05640635

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Jan 2023Dec 2026

First Submitted

Initial submission to the registry

November 16, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

3 years

First QC Date

November 16, 2022

Last Update Submit

June 21, 2024

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress SyndromeExtracorporal membrane oxygenationExtracorporal membrane oxygenation weaningVentilation therapy

Outcome Measures

Primary Outcomes (1)

  • IL-6 concentration (blood samples)

    Daily control of above mentioned parameter.

    For the duration of the ICU stay, or a maximum of 60 days.

Secondary Outcomes (7)

  • SOFA-Score

    For the duration of the ICU stay, or a maximum of 60 days at indicated time points as described above..

  • Ventilation pressures

    For the duration of the artificial ventilation, or a maximum of 60 days.

  • Murray Lung Injury Score (LIS)

    For the duration of the ICU stay, or a maximum of 60 days.

  • Length of stay in the intensive care unit

    For the duration of the ICU stay, or a maximum of 60 days.

  • Ventilator-associated pneumonia

    For the duration of the ICU stay, or a maximum of 60 days.

  • +2 more secondary outcomes

Study Arms (2)

Ventilator weaning first

ACTIVE COMPARATOR
Procedure: Ventilator weaning first

ECMO weaning first

ACTIVE COMPARATOR
Procedure: ECMO weaning first

Interventions

Ventilator weaning firstPROCEDURE

Ventilator weaning initiated and completed before start of ECMO weaning.

Ventilator weaning first
ECMO weaning firstPROCEDURE

ECMO weaning initiated and completed before start of ventilator weaning.

ECMO weaning first

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute respiratory distress syndrome (ARDS) according to the Berlin Definition (PaO2/FiO2 \< 100) and treatment with veno-venous ECMO (vvECMO)
  • Hemodynamic stability
  • Lung compliance did not change/improved during the last 24 hours
  • Tidal volume did not change/improved during the last 24 hours with a PEEP of 10 cmH20 or above
  • Consent of the patient or their legal representative

You may not qualify if:

  • Age \< 18 years
  • Artificial ventilation for more than 7 days prior
  • Patient, legal representative or doctors decided against an unrestricted intensive care treatment
  • Positive pregnancy test at time of screening
  • Cardiac failure requiring veno-arterial ECMO therapy
  • Chronic respiratory insufficiency requiring long-term oxygen treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Peter Rosenberger, Prof.

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Rosenberger, Prof.

CONTACT

+49707129peter.rosenberger@med.uni-tuebingen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2022

First Posted

December 7, 2022

Study Start

January 1, 2023

Primary Completion

January 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 24, 2024

Record last verified: 2024-06

Locations

DE(1)