Estimation of Outcome and Quality of Life in ECMO Patients

NCT06400797 | Recruiting

• 1 other identifier: 2024-RM-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The availability as well as the use of extracorporeal membrane oxygenation (ECMO) systems for severe acute respiratory or cardiocirculatory failure is steadily increasing. The decision to initiate ECMO therapy is predominantly made in emergency situations, for which the focus is on acute survival. The decisions if a patient will profit from ECMO therapy are mainly made from clinical experience and educated guess by the attending team. However, it is unknown how useful these clinical predictions are. Therefore, this observational study will compare estimated and real outcome of ECMO patients.

Conditions

Extracorporeal Membrane Oxygenation

Keywords

ECMO; health related quality of life; Outcome estimation

Outcome Measures

Primary Outcomes (1)

• Agreement between estimated outcome by healthcare providers and actual patient outcome on Modified Rankin scale mRS

  The primary endpoint of this study will be the agreement between functional performance of patients estimated by different healthcare provider groups and actual functional performance of patients after start of ECMO therapy measured by the 7-item mRS.

  6 months and 12 months after ECMO therapy

Secondary Outcomes (3)

• Disability-free survival (WHODAS 2.0)

  6 months and 12 months after ECMO therapy

• Days alive and out of hospital (DAOH)

  6 months and 12 months after ECMO therapy

• Moral distress

  Day 1 and day 4-7 of ECMO therapy

Study Arms (1)

ECMO patients

Patients recieving Venoarterial or Venovenous extracorporeal membrane oxygenation (VA-ECMO, VV-ECMO)

Other: estimation of patient outcome by health care providers

Interventions

estimation of patient outcome by health care providers OTHER

On day 1 after study inclusion as well as day 4-7, the responsible health-care providers (at least one nurse, one resident and one consultant with the board certification intensive care medicine) will estimate the patient's expected functional outcome at 6 and 12 months after the start of ECMO therapy. Health-care providers responsible for the patient at that time will be surveyed (multiple questionnaires to detect specific differences within one person are not planned). For the purpose of functional outcome estimation, the modified Rankin scale (mRS) is used.

ECMO patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients aged above 18 years in the ICU with a vv- or va-ECMO for less than 24 hours will be included.

You may qualify if:

• age ≥ 18 years
• start of ECMO therapy ≤24h
• written informed consent from patient or health-care proxy

You may not qualify if:

• age \< 18 years
• Language barrier (communication in German/local language or English not possible).
• no ECMO therapy or ECMO therapy longer than 24h
• no written consent

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

University Hospital Duesseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Study Officials

• René M'Pembele, MD

  Heinrich-Heine University, Duesseldorf

  PRINCIPAL INVESTIGATOR

• Sebastian Roth, MD

  Heinrich-Heine University, Duesseldorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

René M'Pembele, MD

CONTACT

02118118451; rene.mpembele@med.uni-duesseldorf.de

Sebastian Roth, MD

CONTACT

02118118451; sebastian.roth@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 6, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)