Centre for Clinical Trial Support
PAGE
MENU

Critical Care & Trauma

Current Projects

ABOVE


ABOVE Trial - Advancing Brain Outcomes in pediatric critically ill patients sedated with Volatile anEsthestic agents (ABOVE): A pilot multicentre randomized controlled trial

Principal investigator
Dr. Angela Jerath, Sunnybrook Health Sciences Centre
Dr. Rishi Ganesan, The Children’s Hospital – London Health Sciences Centre
Dr. Nicole McKinnon, The Hospital for Sick Children (SickKids)
Dr. Marat Slessarev, London Health Sciences Centre

Recruitment Status
Recruiting

Summary
The ABOVE Trial is a pilot, multicenter, vanguard randomized controlled trial (RCT) to assess the feasibility of accruing patients, delivering inhaled sedatives, and ascertaining outcomes in preparation for a definitive trial to evaluate if inhaled sedatives (intervention) compared to intravenous (IV) agents (comparator) improve delirium (outcome) in mechanically ventilated critically ill children (population).

Sample Size: This pilot trial aims to recruit 60 children who require mechanical ventilation in the pediatric intensive/critical care unit (PICU/PCCU).

Intervention: Participants will be randomized to either the control arm (IV sedation) or the intervention arm (inhaled sedation).

Outcomes: The primary outcome is patient accrual and identifying barriers to recruitment. Secondary outcomes will assess protocol adherence, attrition rate, safety/adverse event rate, and healthcare team satisfaction.

ClinicalTrials.gov (NCT#)
NCT05867472

Trial email
ABOVETrial@sunnybrook.ca

Trial Locations
The Children’s Hospital – London Health Sciences Centre, London, Ontario
The Hospital for Sick Children (SickKids), Toronto, Ontario

ATTAACH


ATTAACH - Pilot Randomized Controlled Trial of Anticoagulation Therapy Timing in Atrial Fibrillation after Acute and Chronic Subdural Hematoma

Principal investigator
Dr. Farhad Pirouzmand, Sunnybrook Health Sciences Centre

Recruitment Status
Terminated (Halted Prematurely)

Summary
ATTAACH is a pilot, open label, multi-centre, pragmatic randomized controlled trial that is planned to simulate all aspects of a larger definitive trial comparing early versus delayed resumption of anticoagulation for stroke prophylaxis secondary to atrial fibrillation after subdural hematoma (SDH) in appropriately selected patients with atrial fibrillation (AF).

This pilot will help determine the ability to meet pre-specified criteria in identification, recruitment, and participant allocation; allow for refinement of eligibility criteria for optimal recruitment; confirm safety of intervention and; examine the ability to retain participants for the duration of the trial and collect follow-up data. Preliminary efficacy data will inform sample size calculations and estimation of resources required for the envisioned larger definitive trial. If the pilot trial is found to be feasible and there are no major changes to the protocol, then the data will contribute to the final analysis of the definitive trial (i.e., vanguard design).

The study aims to enroll 120 participants over an 18 month period at 7 centres across Canada.

ClinicalTrials.gov (NCT#)
NCT05472766

Trial email
ATTAACH_Trial@sunnybrook.ca

Trial Locations
Ontario

CATCO


CATCO - A Multi-centre, Adaptive, Randomized, Open-label, Controlled Clinical Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Patients

Principal investigator
Dr. Rob Fowler, Sunnybrook Health Sciences Centre
Dr. Srinivas Murthy, University of British Columbia

Recruitment Status
Recruiting completed

Summary
CATCO is a Canadian, Phase III, multi-centre, adaptive, open-label clinical trial, conducted to investigate the safety and efficacy of various therapeutics as a treatment for COVID-19 in hospitalized patients against the current standard of care. CATCO is conducted in collaboration with countries around the world through the World Health Organizations’ (WHO) SOLIDARITY Trial PLUS. Since COVID-19 is a public health emergency that is evolving rapidly, an accurate sample size is impossible to calculate. Interim results will be reviewed at regular intervals. Given the adaptive nature of the trial, the study interventions change frequently based on interim analysis. Current information on the active study interventions/drugs can be found at ClinicalTrials.gov. The primary objective of the trial is to evaluate the clinical effectiveness of the study drugs, relative to the standard of care arm, in patients hospitalized with COVID-19, through study drug specific outcomes.

ClinicalTrials.gov (NCT#)
NCT04330690

Trial email
CATCO@sunnybrook.ca

Trial Locations

  1. Ontario
    1. Toronto
    2. London
    3. Markham
    4. Ottawa
    5. Niagara
    6. Scarborough
    7. Hamilton
    8. Kitchener
    9. Thunder bay
    10. Mississauga
    11. Etobicoke
  2. Alberta
    1. Edmonton
    2. Calgary
  3. British Columbia
    1. Vancouver
    2. North Vancouver
    3. Richmond
    4. Victoria
    5. Kamloops
  4. Quebec
    1. Quebec City
    2. Montreal
    3. Sherbrooke
    4. Levis
  5. Manitoba
    1. Winnipeg
  6. Newfoundland
    1. St. John’s
  7. New Brunswick
    1. Moncton
  8. Saskatchewan
    1. Regina
    2. Saskatoon
  9. Nova Scotia
    1. Halifax

Social Media links

  1. Follow CATCO on X @CATCOTrial
  2. Sunnybrook COVID-19 Research Webpage
  3. Canadian Critical Care Trials Group (CCCTG) website

Publications

  1. Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trail
  2. Remdesivir in Patients with Severe Kidney Dysfunction
  3. Cost-effectiveness of remdesivir plus usual care versus usual care alone for hospitalized patients with COVID-19
  4. WHO SOLIDARITY Publications, which included CATCO Data
    1. Repurposed Antiviral Drugs for COVID-19 – Interim WHO SOLIDARITY Trial Results
    2. Remdesivir and three other drugs for hospitalised patients with COVID-19: final results of the WHO Solidarity randomised trial and updated meta-analyses

HONOUR


HONOUR - High-Flow Nasal Oxygen with or without Helmet Non-invasive Ventilation for Oxygenation Support in Acute Respiratory Failure (HONOUR) Pilot RCT

Principal investigator
Dr. Damon Scales, Sunnybrook Health Sciences Centre
Dr. Niall Ferguson, University Health Network-Toronto General Hospital

Recruitment Status
Recruiting

Summary
HONOUR is a pilot, open-label randomized controlled trial to assess the feasibility of conducting a large multicenter randomized controlled trial. It will directly compare helmet non-invasive ventilation (NIV) combined with high flow nasal oxygen (HFNO) versus HFNO alone in patients with AHRF. The projected sample size is 200 participants across 10-15 Canadian sites, and the primary outcomes are:

  1. To determine whether it is feasible to recruit 1 patient per month per participating centre, and to estimate the potential recruitment rate for the full trial.
  2. To assess the proportion of eligible patients who are not randomized (and their reasons).
  3. To determine the rate of adherence to the assigned oxygenation strategy (and crossover rate).
  4. To estimate the adherence to pre-specified intubation criteria.
  5. To estimate the median time from ICU admission to randomization and initiation of the allocated treatment, and time from initiation of any supplemental oxygen to randomization.

ClinicalTrials.gov (NCT#)
NCT05078034

Trial email
HONOUR@sunnybrook.ca

Trial Locations
Toronto, Ontario; Hamilton, Ontario, London, Ontario; Kingston, Ontario; Ottawa, Ontario, Calgary, Alberta; Edmonton, Alberta

Social Media links
X: @HONOUR_Trial

PROTEST

PROTEST - PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury, a double-blind Randomized Controlled Trial

Principal investigators
Dr. Damon Scales, Sunnybrook Health Sciences Centre
Dr. Farhad Pirouzmand, Sunnybrook Health Sciences Centre

Recruitment Status
Recruiting

Summary

This pragmatic RCT will directly compare the effectiveness and safety of two Venous thromboembolism (VTE) thromboprophylaxis strategies during the critical first week after severe traumatic brain injury (TBI): (1) placebo versus (2) prompt administration of study drug (Dalteparin) for 7 days. The trial will enroll 1100 participants across Canada.

The primary effectiveness outcome is clinically important VTE to Day 8.

The primary safety outcome is clinically important intracranial bleed (ICB) progression to Day 8.

ClinicalTrials.gov (NCT#)
NCT03559114

Trial email
PROTEST@sunnybrook.ca

Trial Locations

  • Toronto
  • Ottawa
  • Kingston
  • Hamilton
  • Saskatoon
  • Calgary
  • Edmonton
  • Quebec City
  • Vancouver
  • Halifax

SAVE-ICU


SAVE-ICU - SedAting With Volatile Anesthetics Critically Ill COVID-19 Patients in ICU: Effects On Ventilatory Parameters And Survival

Principal investigators
Dr. Angela Jerath, Sunnybrook Health Sciences Centre
Dr. Brian Cuthbertson, Sunnybrook Health Sciences Centre
Dr. Marat Slessarev, London Health Sciences Centre
Dr. Claudio Martin, London Health Sciences Centre

Recruitment Status
Recruiting

Summary
SAVE-ICU is a multi-centre, randomized clinical trial studying the effectiveness of inhaled volatile sedation versus intravenous sedation for COVID-19 patients that need to be placed on a ventilator.

The purpose of the study is to evaluate whether inhaled volatile sedation can be used effectively in ventilated COVID-19 patients, thereby easing pressure on IV sedation stocks. The study is also evaluating if patients recover faster with this form of sedation.

Sample Size: 758 participants

Interventions: Participants will be randomized to either an intravenous or inhaled volatile-based sedation arm.

Primary Outcomes:

  1. Hospital Mortality with 10% difference between groups (752 participants),
  2. Ventilator-free-days at day 30 after enrollment (200 patients)
  3. Quality of life using EQ-5D at 90 days and 365 days after enrollment (144 participants)
  4. ICU-free-days at day 30 after enrollment (128 participants)

ClinicalTrials.gov (NCT#)
NCT04415060

Trial email
SAVE-ICU@sunnybrook.ca

Trial Locations

  • Sunnybrook Health Sciences Centre (Toronto, Ontario, Canada)
  • London Health Sciences Centre – Victoria Hospital (London, Ontario, Canada)
  • London Health Sciences Centre – University Hospital (London, Ontario, Canada)
  • UHN - Toronto General Hospital (Toronto, Ontario, Canada)
  • UHN - Toronto Western Hospital (Toronto, Ontario, Canada)
  • The Ottawa Hospital – Civic Campus (Ottawa, Ontario, Canada)
  • The Ottawa Hospital – General Campus (Ottawa, Ontario, Canada)
  • University of Alberta Hospital (Edmonton, Alberta, Canada)
  • Grey Nuns Community Hospital (Edmonton, Alberta, Canada)
  • Centre Hospitalier de l'Université de Montréal (CHUM) (Montréal, Québec, Canada)
  • Centre Intégré Universitaire de Santé et Services Sociaux de l’Estrie – Centre Hospitalier Universitaire de Sherbrooke (CHUS) (Sherbrooke, Québec, Canada)
  • Centre Intégré et Universitaire de Santé et Services Sociaux du Nord de l'île de Montréal (CIUSSE-NIM-HSCM) (Montréal, Québec, Canada)
  • Institut Universitaire de Cardiologie et Pneumologie de Québec (IUCPQ) (Laval, Québec, Canada)
  • McGill University Health Centre – Royal Victoria Hospital (Montréal, Québec, Canada)
  • McGill University Health Centre – Montreal General Hospital (Montréal, Québec, Canada)
  • Massachusetts General Hospital (Boston, Massachusetts, United States)

Social Media links
www.saveicu.com
Follow SAVE-ICU on X @SaveIcu

Publications

  1. Gorsky K, Cuninghame S, Chen J, Jayaraj K, Withington D, Francoeur C, Slessarev M, Jerath A. Use of inhalational anaesthetic agents in paediatric and adult patients for status asthmaticus, status epilepticus and difficult sedation scenarios: a protocol for a systematic review. BMJ Open. 2021 Nov 10; 11(11):e051745. doi: 10.1136/bmjopen-2021-051745. PMID: 34758996; PMCID: PMC8587357. https://bmjopen.bmj.com/content/11/11/e051745.long
  1. Cuninghame S, Gorsky K, Francoeur C, Withington D, Burry L, Jerath A,Slessarev M. Effect of sedation with inhaled anaesthetics on cognitive and psychiatric outcomes in critically ill adults: a systematic review protocol. BMJ Open. 2022 Feb 7; 12(2):e052893. doi: 10.1136/bmjopen-2021-052893. PMID:35131825; PMCID: PMC8822506 https://bmjopen.bmj.com/content/12/2/e052893.long 

SuDDICU


SuDDICU - A randomized controlled trial of the effectiveness and cost-effectiveness and a contemporaneous study of the ecological impact of Selective Decontamination of the Digestive tract in critically ill patients treated in Intensive Care Units.

Principal investigator
Dr. Brian Cuthbertson, Sunnybrook Health Sciences Centre

Recruitment Status
Recruiting completed

Summary
Critically ill patients are particularly at risk of hospital acquired infections and are susceptible to higher mortality rate in addition to higher healthcare expenses. Selective decontamination of the digestive tract (SDD) is an infection-control strategy designed to reduce mortality by preventing sepsis. Suddicu is an international, investigator-initiated research collaboration with sites in Canada, Australia, and the U.K.

It is a randomized trial comparing the effect of using SDD plus standard care, to standard care alone on hospital mortality in patients receiving mechanical ventilation in the intensive care unit (ICU).

Intervention: This is an international, multicentre, crossover, cluster randomized controlled trial (x-cRCT) of eligible patients in participating ICUs using two 12-month interventional trial periods separated by a 3-month inter-period gap.

  1. Topical application of antibiotic paste to mouth and throat
  2. Administration of antibiotic suspension in stomach
  3. A short four-day course of an intravenous antibiotic. Patients already receiving an alternative IV antibiotic as clinically indicated will not receive an additional intravenous antibiotic, but will continue the prescribed antibiotic for the usual duration of therapy.

The primary outcome is All-cause hospital mortality. This trial will answer if SDD regimen drives unknown fear of antibiotic resistance which is a threat to public health or will it prove to have a global impact by preventing infections, saving lives and reducing healthcare costs.

The trial has enroll 5000+ participants in Canada as of September 2022 and a total of 14000 patients world-wide.

ClinicalTrials.gov (NCT#)
NCT02389036

Trial email
suDDICU@sunnybrook.ca

Trial Locations

  • Ontario, Canada (7): Toronto (2), Hamilton, Niagara, Kingston, London (2)
  • UK (3)
  • Australia (19)

Social media links

1. Follow SuDDICU on X @suddicu

  1. Study page (Sunnybrook website)
  1. Study page (Canadian Critical Care Trials Group)