Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05440851

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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