Inflammation During ECMO Therapy and ECMO Weaning | NCT05640635

Studies
Inflammation During ECMO Therapy and ECMO Weaning

NCT05640635

Sponsor

University Hospital Tuebingen

Status

Recruiting

Last Update Posted

Jun 24, 2024Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Acute Respiratory Distress Syndrome

Interventions

Ventilator weaning first
ECMO weaning first

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Jan 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Nov 16, 2022

First Submission Date that Met QC Criteria

Nov 28, 2022

First Posted Date

Dec 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2024

Last Update Posted Date

Jun 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ventilator weaning first	Active Comparator		Procedure: Ventilator weaning first
ECMO weaning first	Active Comparator		Procedure: ECMO weaning first

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ventilator weaning first	Procedure	Ventilator weaning initiated and completed before start of ECMO weaning.	Ventilator weaning first

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
SOFA-Score	Sequential organ failure assessement score evaluated at days 1-14, 28, and 60.	For the duration of the ICU stay, or a maximum of 60 days at indicated time points as described above..
Ventilation pressures

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peter Rosenberger, Prof.	Contact	+49707129	86622	peter.rosenberger@med.uni-tuebingen.de

Overall Officials

Name	Affiliation	Role
Peter Rosenberger, Prof.	University Hospital Tuebingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Tuebingen	Recruiting	Tübingen	Baden-Wurttemberg	72076	Germany

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

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Browse Branches

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