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NCT05440851 · ClinicalTrials.gov registry record · NA

Platform of Randomized Adaptive Clinical Trials in Critical Illness

A NA study of Respiratory Insufficiency and Extracorporeal Membrane Oxygenation Complication, sponsored by University Health Network, Toronto.

Recruiting
Registry status
NA
Development phase
6,250
Enrollment target
20
Study locations

NCT05440851 is a NA study of Respiratory Insufficiency and Extracorporeal Membrane Oxygenation Complication that is actively recruiting participants, run by University Health Network, Toronto. The registered enrollment target is 6,250 participants, above the 126-participant average among 10 other Respiratory Insufficiency trials with a reported enrollment target (4860% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT05440851, a NA study of Respiratory Insufficiency and Extracorporeal Membrane Oxygenation Complication, is actively recruiting participants, sponsored by University Health Network, Toronto.

RECRUITING
Registry status
NA
Development phase
6,250 participants
Enrollment target
20
Study locations

Study Summary

PRACTICAL is a randomized multifactorial adaptive platform trial for acute hypoxemic respiratory failure (AHRF). This platform trial will evaluate novel interventions for patients with AHRF across a range of severity states (i.e., not intubated, intubated with lower or higher respiratory system elastance, requiring extracorporeal life support) and across a range of investigational phases (i.e., preliminary mechanistic trials, full-scale clinical trials). AHRF is a common and life-threatening clinical syndrome affecting millions globally every year. Patients with AHRF are at high risk of death and long-term morbidity. Patients who require invasive mechanical ventilation are at risk of ventilator-induced lung injury and ventilator-induced diaphragm dysfunction. New treatments and treatment strategies are needed to improve outcomes for these very ill patients. Utilizing advances in Bayesian adaptive trial design, the platform will facilitate efficient yet rigorous testing of new treatments for AHRF, with a particular focus on mechanical ventilation strategies and extracorporeal life support techniques as well as pharmacological agents and new medical devices. The platform is designed to enable evaluation of novel interventions at a variety of stages of investigation, including pilot and feasibility trials, trials focused on mechanistic surrogate endpoints for preliminary clinical evaluation, and full-scale clinical trials assessing the impact of interventions on patient-centered outcomes. Interventions will be evaluated within therapeutic domains. A domain is defined as a set of interventions that are intended to act on specific mechanisms of injury using different variations of a common therapeutic strategy. Domains are intended to function independently of each other, allowing independent evaluation of multiple therapies within the same patient. Once feasibility is established, Bayesian adaptive statistical modelling will be used to evaluate treatment efficacy at

Conditions Studied

Respiratory Insufficiency Extracorporeal Membrane Oxygenation Complication Mechanical Ventilation Pressure High

Interventions

  • OTHER Ultra-Protective Ventilation Facilitated by Extracorporeal Support
  • OTHER Lung-Protective Ventilation (LPV)
  • OTHER Driving Pressure-Limited Ventilation (DPL)
  • OTHER Lung- and Diaphragm-Protective Ventilation and Sedation (LDPVS)
  • DRUG Early Cohort corticosteroid dose

Study Locations (20)

California

  • University of California Los Angeles (UCLA) - Los Angeles
  • University of San Diego (UCSD) - San Diego
  • University of California San Francisco - San Francisco

Maryland

  • University of Maryland Medical System - Baltimore
  • The Johns Hopkins Medicine - Baltimore

Michigan

  • VA Ann Arbor Healthcare System - Ann Arbor
  • University of Michigan Health - Ann Arbor

New York

  • Mount Sinai New York City - New York
  • Columbia University Irving Medical Center - New York

Ohio

  • University of Cincinnati College of Medicine - Cincinnati
  • Cleveland Clinic - Cleveland

Pennsylvania

  • University of Pennsylvania - Philadelphia
  • Thomas Jefferson University Hospital - Philadelphia

Arizona

  • University of Arizona - Tucson

Colorado

  • University of Colorado Hospital - Aurora

Trial Details

FieldValue
Enrollment Target 6,250 participants
Start Date 2023-04-30
Est. Completion 2027-03-31
Phase NA

Sponsor

University Health Network, Toronto

23 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05440851

The ClinicalTrials.gov registry entry for NCT05440851 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 6,250 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 126-participant average among 10 other Respiratory Insufficiency trials with a reported enrollment target (4860% higher). The listed sponsor is University Health Network, Toronto, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Respiratory Insufficiency appearing as the primary indexed condition, and to 5 interventions - of which Ultra-Protective Ventilation Facilitated by Extracorporeal Support is the first listed.

NCT05440851 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Maryland, Michigan.

Frequently Asked Questions

What is clinical trial NCT05440851 about?

NCT05440851 is a clinical study titled "Platform of Randomized Adaptive Clinical Trials in Critical Illness". PRACTICAL is a randomized multifactorial adaptive platform trial for acute hypoxemic respiratory failure (AHRF). This platform trial will evaluate novel interventions for patients with AHRF across a range of severity states (i.e., not intubated, intubated with lower or higher respiratory system elas...

What is the current status of trial NCT05440851?

This trial is currently recruiting. It is a NA study. The enrollment target is 6,250 participants. The study started on 2023-04-30. Estimated completion is 2027-03-31.

What conditions does trial NCT05440851 study?

This clinical trial studies the following conditions: Respiratory Insufficiency, Extracorporeal Membrane Oxygenation Complication, Mechanical Ventilation Pressure High.

What interventions are being tested in trial NCT05440851?

The interventions under investigation include: Ultra-Protective Ventilation Facilitated by Extracorporeal Support (OTHER), Lung-Protective Ventilation (LPV) (OTHER), Driving Pressure-Limited Ventilation (DPL) (OTHER), Lung- and Diaphragm-Protective Ventilation and Sedation (LDPVS) (OTHER), Early Cohort corticosteroid dose (DRUG).

Who is sponsoring clinical trial NCT05440851?

This trial is sponsored by University Health Network, Toronto, which has 23 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05440851 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.