NCT03841084: BLENDER

Blend to Limit Oxygen in ECMO: A Randomised Controlled Registry Trial

Completed Phase 2 Last updated 9 August 2024

What this trial tests

Phase 2 trial testing Oxygen in Cardiac Failure in 300 participants. Completed in 1 July 2023.

Timeline

18 September 2019

Primary endpoint
3 June 2023

1 July 2023

Quick facts

Lead sponsor	Australian and New Zealand Intensive Care Research Centre
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	18 September 2019
Primary completion	3 June 2023
Estimated completion	1 July 2023
Sites	1 location across Australia

Drugs / interventions tested

• Oxygen — full drug profile →

Conditions studied

• Cardiac Failure — all drugs for Cardiac Failure →
• Critical Illness — all drugs for Critical Illness →

Sponsor

Australian and New Zealand Intensive Care Research Centre — full company profile →

Who can join

18 and older, any sex, with Cardiac Failure or Critical Illness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To determine in patients requiring venoarterial (V-A) ECMO, whether the use of a conservative as compared with liberal oxygen strategy, results in a greater number of ICU-free days at day 28.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. In-Depth Extracorporeal Cardiopulmonary Resuscitation in Adult Out-of-Hospital Cardiac Arrest.
   Dennis M, Lal S, Forrest P, Nichol A, et al · · 2020 · cited 55× · PMID 32375010 · DOI 10.1161/jaha.120.016521
2. The association of modifiable mechanical ventilation settings, blood gas changes and survival on extracorporeal membrane oxygenation for cardiac arrest.
   Tonna JE, Selzman CH, Bartos JA, Presson AP, et al · · 2022 · cited 41× · PMID 35331803 · DOI 10.1016/j.resuscitation.2022.03.016
3. Early hyperoxia and 28-day mortality in patients on venoarterial ECMO support for refractory cardiogenic shock: a bicenter retrospective propensity score-weighted analysis.
   Moussa MD, Beyls C, Lamer A, Roksic S, et al · · 2022 · cited 27× · PMID 36028883 · DOI 10.1186/s13054-022-04133-7
4. Optimizing PO₂ during peripheral veno-arterial ECMO: a narrative review.
   Winiszewski H, Guinot PG, Schmidt M, Besch G, et al · · 2022 · cited 23× · PMID 35883117 · DOI 10.1186/s13054-022-04102-0
5. Conservative or liberal oxygen targets in patients on venoarterial extracorporeal membrane oxygenation.
   Burrell A, Bailey MJ, Bellomo R, Buscher H, et al · · 2024 · cited 13× · PMID 39162827 · DOI 10.1007/s00134-024-07564-8
6. Blend to Limit OxygEN in ECMO: A RanDomised ControllEd Registry (BLENDER) Trial: Study Protocol and Statistical Analysis Plan.
   Burrell A, Ng S, Ottosen K, Bailey M, et al · · 2023 · cited 5× · PMID 37876374 · DOI 10.1016/j.ccrj.2023.06.001
7. Hyperoxia during venoarterial ECMO: Culprit or co-variate? A comment from the BLENDER investigators.
   Premraj L, Brown A, Burrell A, Fraser JF, et al · · 2022 · cited 2× · PMID 36348428 · DOI 10.1186/s13054-022-04213-8
8. Early hyperoxia and 28-day mortality in patients on venoarterial ECMO support for refractory cardiogenic shock: discussion about potential confounding factors.
   Winiszewski H, Piton G, Capellier G. · · 2022 · cited 2× · PMID 36253862 · DOI 10.1186/s13054-022-04181-z