Actively Recruiting
Platform of Randomized Adaptive Clinical Trials in Critical Illness Evaluating Treatments for Acute Hypoxemic Respiratory Failure Using Mechanical Ventilation, Extracorporeal Support, and Drug Therapies
Led by University Health Network, Toronto · Updated on 2026-05-07
6250
Participants Needed
89
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating new treatments for acute hypoxemic respiratory failure (AHRF), a serious condition that affects millions worldwide each year and carries high risks of death and long-term health problems. This platform trial, called PRACTICAL, uses adaptive methods to test various interventions at different stages, including mechanical ventilation approaches, extracorporeal life support, drugs, and medical devices. The study aims to find better strategies to protect lungs and diaphragm function during ventilation and improve patient outcomes. The trial includes multiple domains studying different treatments or strategies. These include ultra-protective ventilation using extracorporeal carbon dioxide removal, various invasive mechanical ventilation strategies, corticosteroid use in early and extended phases, nebulized furosemide, positive end-expiratory pressure settings during extracorporeal support, fludrocortisone for airspace disease, and inspiratory muscle training. Some domains are observational, collecting data and biomarkers in immunocompromised patients or examining patient-ventilator interactions. Participants will be randomized to different treatment arms or observed, depending on the domain. Participants will undergo assessments including physiological and biological measurements, mechanical ventilation monitoring, and evaluation of clinical outcomes such as mortality, ventilator-free days, organ failure, and long-term cognitive and physical function. Data will be collected daily or at specified time points up to 180 days. The study uses Bayesian adaptive analysis to efficiently evaluate efficacy and safety of interventions. The total participation time varies by domain but includes active treatment periods, follow-up, and feasibility assessments over months to years.
CONDITIONS
Brief Title
Platform of Randomized Adaptive Clinical Trials in Critical Illness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute hypoxemic respiratory failure with new or worsening symptoms within 2 weeks prior to needing oxygen or respiratory support
- Receiving oxygen or respiratory support at 10 L/min or higher, high flow nasal oxygen, invasive ventilation, extracorporeal life support, or non-invasive ventilation for at least 4 hours
- Minimum FiO2 of 0.40 or oxygen flow rate of 10 L/min on face mask for at least 4 hours unless on extracorporeal life support
- Age 18 years or older
- Hypoxemia not mainly caused by acute heart failure, fluid overload, or pulmonary embolism
- Specific domain criteria such as invasive mechanical ventilation duration, respiratory elastance levels, or immunocompromised status depending on the domain
You will not qualify if you...
- Planned or anticipated extubation on the day of screening
- Planned or anticipated ICU discharge on the day of screening
- Moribund patients unlikely to survive 24 hours
- Transition to fully palliative care
- For some domains: age over 70 years, current extracorporeal life support use, chronic hypercapnic respiratory failure, home mechanical ventilation (except certain sleep therapies), severe hypoxemia or hypercapnia, expected mechanical ventilation duration less than 48 hours, neuromuscular disorders, severe brain injury, weight less than 35 kg, pregnancy, or allergies to study drugs
- Known hypersensitivity to study drugs like fludrocortisone or furosemide
- Participation in conflicting trials or conditions making study participation unsafe or inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 25 days or until ICU discharge or death, whichever comes first
Participants receive assigned interventions including various mechanical ventilation strategies, corticosteroids, nebulized medications, or other supportive care according to their randomized group.
Daily assessments during ICU stay up to 25 days
Duration - Up to 6 months after treatment
Participants are monitored for clinical outcomes, safety, and recovery including survival, ventilator-free days, cognitive and physical function assessments up to 6 months after enrollment.
Follow-up visits or contacts at Day 28, Day 60, Day 90, and Day 180
Trial Site Locations
Total: 89 locations
1
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
2
University of California Los Angeles (UCLA)
Los Angeles, California, United States, 90095
Actively Recruiting
3
University of San Diego (UCSD)
San Diego, California, United States, 92121
Actively Recruiting
4
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
5
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
6
University of Kentucky
Lexington, Kentucky, United States, 40506
Actively Recruiting
7
University of Maryland Medical System
Baltimore, Maryland, United States, 21201
Actively Recruiting
8
The Johns Hopkins Medicine
Baltimore, Maryland, United States, 21224
Actively Recruiting
9
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48105
Not Yet Recruiting
10
University of Michigan Health
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
11
Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
12
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
13
Mount Sinai New York City
New York, New York, United States, 10029
Actively Recruiting
14
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
15
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27101
Actively Recruiting
16
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267
Actively Recruiting
17
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
18
Oregon Health & Science University (OHSU)
Portland, Oregon, United States, 97239
Actively Recruiting
19
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
20
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
21
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
22
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
23
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Actively Recruiting
24
Vanderbilt university medical center
Nashville, Tennessee, United States, 37232
Actively Recruiting
25
University of Utah Health
Farmington, Utah, United States, 84025
Actively Recruiting
26
Sentara Health
Norfolk, Virginia, United States, 23507
Actively Recruiting
27
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
28
Nepean Hospital
Kingswood, New South Wales, Australia, 2747
Actively Recruiting
29
Wollongong Hospital
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
30
Flinders Medical Centre
Bedford Park, Southern Adelaide, Australia, 5042
Actively Recruiting
31
St Vincents Sydney
Darlinghurst, Sydney, Australia, 2010
Actively Recruiting
32
Bendigo Health Victoria
Bendigo, Victoria, Australia, 3550
Actively Recruiting
33
University Hospital Geelong
Geelong, Victoria, Australia, 3220
Actively Recruiting
34
The Austin Hospital
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
35
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Actively Recruiting
36
University of Alberta/Edmonton University Hospital
Edmonton, Alberta, Canada, T6G 2X8
Actively Recruiting
37
Nanaimo Regional General Hospital
Nanaimo, British Columbia, Canada, V9S 2B7
Actively Recruiting
38
Surrey Memorial Hospital
Surrey, British Columbia, Canada, V3V 1Z2
Actively Recruiting
39
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Actively Recruiting
40
Royal Jubilee Hospital
Victoria, British Columbia, Canada, V8R 1J8
Actively Recruiting
41
Vancouver Island Health - Royal Jubilee Hospital & Nanaimo Hospital
Victoria, British Columbia, Canada, V8R 1J8
Actively Recruiting
42
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Actively Recruiting
43
Health Sciences Centre - Winnipeg
Winnipeg, Manitoba, Canada, R3A 1R9
Actively Recruiting
44
Grace Hospital
Winnipeg, Manitoba, Canada, R3J 3M7
Actively Recruiting
45
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3S 0H6
Actively Recruiting
46
William Osler Health System
Brampton, Ontario, Canada, L6R 3J7
Actively Recruiting
47
Brantford General Hospital
Brantford, Ontario, Canada, N3R 1G9
Actively Recruiting
48
Hamilton Health Sciences Centre - General
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
49
St. Joseph's Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Actively Recruiting
50
Hamilton Health Sciences Centre - Juravinski
Hamilton, Ontario, Canada, L8V 1C3
Actively Recruiting
51
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
52
London Health Sciences Centre - University Hospital
London, Ontario, Canada, N6A 5W9
Not Yet Recruiting
53
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada, N6A 5W9
Not Yet Recruiting
54
Oak Valley Health
Markham, Ontario, Canada, L3P 7P3
Actively Recruiting
55
North York General Hospital
North York, Ontario, Canada, M2K 1E1
Actively Recruiting
56
Halton Healthcare
Oakville, Ontario, Canada, L6M 0L8
Actively Recruiting
57
Lakeridge Hospital
Oshawa, Ontario, Canada, L1G 8A2
Actively Recruiting
58
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
59
Ottawa Heart Research Institute
Ottawa, Ontario, Canada, K1Y 4W7
Not Yet Recruiting
60
Mackenzie Health
Richmond Hill, Ontario, Canada, L4C 4Z3
Actively Recruiting
61
Niagara Health Systems
Saint Catherines, Ontario, Canada, L2S 0A9
Actively Recruiting
62
Scarborough Health Network
Toronto, Ontario, Canada, M1P 2V5
Actively Recruiting
63
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
64
Unity Health Toronto
Toronto, Ontario, Canada, M5C 2T2
Actively Recruiting
65
Sinai Health, Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Actively Recruiting
66
University Health Network
Toronto, Ontario, Canada
Actively Recruiting
67
Cortellucci Vaughan Hospital
Vaughan, Ontario, Canada, L6A 4Z3
Actively Recruiting
68
Windsor Regional Health
Windsor, Ontario, Canada, N8W 1L9
Actively Recruiting
69
Cité de la Santé Hospital
Laval, Quebec, Canada, H7M 3L9
Not Yet Recruiting
70
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 0C1
Actively Recruiting
71
MUHC - McGill University Health Centre (Glen Site)
Montreal, Quebec, Canada, H4A 0B1
Actively Recruiting
72
Sacre Coeur du Montreal
Montreal, Quebec, Canada, H4J 1C5
Actively Recruiting
73
Centre Hospitalier Universite de Sherbrooke
Sherbrooke, Quebec, Canada, J1J 3H5
Actively Recruiting
74
Trois Riviere (CHAUR)
Trois-Rivières, Quebec, Canada, G8Z 3R9
Actively Recruiting
75
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
Actively Recruiting
76
Clínica Universidad de La Sabana
Chía, Cundinamarca, Colombia
Actively Recruiting
77
Universidad de La Sabana
Chía, Cundinamarca, Colombia
Actively Recruiting
78
Azienda Socio-Sanitaria Territoriale Ovest Milanese
Legnano, MI, Italy, 20025
Actively Recruiting
79
Ospedale Maggiore, Fondazione IRCCS Ca Granda, Milano
Milan, MI, Italy, 20122
Actively Recruiting
80
ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, Italy, 20162
Actively Recruiting
81
Auckland City Hospital
Grafton, Auckland, New Zealand, 1023
Actively Recruiting
82
Middlemore Hospital
Auckland, New Zealand, 2025
Actively Recruiting
83
Taranaki Base Hospital
New Plymouth, New Zealand, 4310
Actively Recruiting
84
Rotorua Hospital
Rotorua, New Zealand, 3010
Actively Recruiting
85
King Abdulaziz Medical City- Riyadh
Riyadh, Saudi Arabia, 11426
Actively Recruiting
86
National University of Singapore
Singapore, Singapore, 119077
Actively Recruiting
87
Parc Taulí University Hospital
Sabadell, Barcelona, Spain, 08208
Active, Not Recruiting
88
Hospital Universitario de Getafe
Getafe, Madrid, Spain, 28905
Not Yet Recruiting
89
Hospital Josep Trueta (Girona)
Girona, Spain, 17007
Actively Recruiting
Research Team
R
Rongyu ( Cindy) Jin
C
Cathy Chau
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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