NCT03981393

Brief Summary

Clinical reasoning and recent data suggest that early use of venovenous extracorporeal membrane oxygenation in refractory respiratory failure may confer a survival advantage. This retrospective matched study will assess whether patients who received VV ECMO at less severe hypoxaemia had differing outcomes to those who received ECMO with very severe hypoxaemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
667

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2011

Longer than P75 for all trials

Status
completed

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 Start

First participant enrolled

December 1, 2011

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

6.1 years

First QC Date

June 6, 2019

Last Update Submit

April 23, 2021

Conditions

Acute Respiratory FailureECMO

Outcome Measures

Primary Outcomes (1)

  • Survival to ECMO ICU discharge

    Percentage of patients alive at discharge from the ICU at the specialist ECMO centre

    Up to 90 days.

Secondary Outcomes (1)

  • Duration of ECMO treatment

    Up to 90 days.

Study Arms (2)

'Less severe hypoxaemia'

PaO2/FiO2 ratio \> 68 mmHg (9.1kPa) at decision-to-cannulate

'Very severe hypoxaemia'

PaO2/FiO2 ratio ≤ 68 mmHg (9.1kPa) at decision-to-cannulate

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a prespecified secondary analysis of the UK ECMO registry. Inclusion criteria are ultimately at the discretion of each recruiting centre, but includes adult patients with potentially reversible acute respiratory failure without absolute contraindications to ECMO therapy.

You may qualify if:

  • Patients included in the UK ECMO registry (see previous registration; NCT number awaited; protocol ECMO-001)
  • Patients with VV ECMO

You may not qualify if:

  • Patients with inadequate or missing data for creation of propensity score models.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic Foundation Doctor

Study Record Dates

First Submitted

June 6, 2019

First Posted

June 10, 2019

Study Start

December 1, 2011

Primary Completion

December 31, 2017

Study Completion

March 31, 2018

Last Updated

April 27, 2021

Record last verified: 2021-04