ANZICS CTG supported Study

DRIVE RCT – NZ

DRIVing PrEssure Limited Ventilation in Hypoxemic Respiratory Failure–Randomised Control Trial

Study Description

For any given state and site, patients will be randomised equally between all interventions available in that state and at that site. All sites will randomize to the control arm and at least one other arm.

Background: Acute hypoxemic respiratory failure (AHRF) is a common, life-threatening condition associated with substantial morbidity and mortality. Many acute and critical illnesses can cause AHRF, defined as a requirement for invasive or non-invasive ventilatory support in patients with a  PaO2/FiO2  ratio  of  300  mmHg  or  less.  Patients  with  AHRF  are  vulnerable  to  nosocomial complications  of  critical  care,  and  lung  and  diaphragm  injury  associated  with  mechanical ventilation.  While  substantial  progress  has  been  made  to  reduce  these  risks  and  improve outcomes, many aspects of care for patients with AHRF remain untested and poorly defined. Novel approaches require careful evaluation in early phase studies to assess their potential to benefit patients before evaluation in larger phase III trials. This platform trial will enable pilot, phase  II  and  phase  III  studies  of  a  range  of  potential  interventions  and  strategies  to improve outcomes for patients with AHRF.

Aim: The primary objective of this adaptive platform trial is to test the feasibility and/or efficacy of interventions for patients with AHRF on mechanistic surrogate endpoints and short-term and long-term patient-centered outcomes.

Management Committee

Ewan Goligher, Lorenzo del Sorbo, Eddy Fan, Niall Ferguson, Ewan Goligher, Anna Heath, Laveena Munshi, John Muscedere, Bram Rochwerg, Sarina Sahetya, Irene Watpool

Administering Institution

University Health Network

Sample size

140

Funding

Canadian Institute of Health research

Reference

CTG2324-01

Contact

Rachael Parke (email)