The University of Freiburg Medical Center Extracorporeal Organ Support Device Registry

March 31, 2023 updated by: PD Dr. Alexander Supady, University Hospital Freiburg
A prospective registry collecting pseudonymized clinical and treatment data from all patients treated with extracorporeal organ support (i.e., VV ECMO, VA ECMO, ECPR, Impella, IABP, and others) on the wards of the Department of Interdisciplinary Medical Intensive Care at the Freiburg University Medical Center.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients receiving extracorporeal organ support and being treated in the Department of Interdisciplinary Medical Intensive Care of the Freiburg University Medical Center

Description

Inclusion Criteria:

  • Treatment with any kind of extracorporeal organ support

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital survival
Time Frame: 30 days
Survival of index hospitalization (yes/no)
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mesenteric ischemia
Time Frame: 30 days
Occurrence of mesenteric ischemia
30 days
Fluid balance
Time Frame: 7 days
Patient fluid balance (difference between fluid input and output)
7 days
ECMO run-time
Time Frame: 60 days
Duration of ECMO support
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Freiburg

Investigators

  • Study Director: Tobias Wengenmayer, Prof. Dr., University of Freiburg
  • Principal Investigator: Dawid L Staudacher, PD Dr., University of Freiburg
  • Principal Investigator: Paul M Biever, Dr., University of Freiburg
  • Principal Investigator: Jonathan Rilinger, PD Dr., University of Freiburg
  • Principal Investigator: Alexander Supady, PD Dr., University of Freiburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2014

Primary Completion (Anticipated)

December 31, 2030

Study Completion (Anticipated)

December 31, 2035

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

March 31, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 151/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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