NCT02860364

Brief Summary

Hypothermic circulatory arrest is an important surgical technique, allowing complex aortic surgeries to be performed safely. Hypothermic circulatory arrest provides protection to cerebral and visceral organs, but may result in longer cardiopulmonary bypass times during surgery, increased risks of bleeding, inflammation, and neuronal injury. To manage these consequences, a trend towards warmer core body temperatures during circulatory arrest has emerged. This trial will randomize patients to either mild (32°C) or moderate (26°C) hypothermia during aortic hemiarch surgery to determine if mild hypothermia reduces the length of cardiopulmonary bypass time and other key measures of morbidity and mortality.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P75+ for not_applicable

Timeline
56mo left

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
2 countries

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Feb 2018Dec 2030

First Submitted

Initial submission to the registry

August 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
1.5 years until next milestone

Study Start

First participant enrolled

February 20, 2018

Completed
12.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

12.8 years

First QC Date

August 4, 2016

Last Update Submit

September 18, 2025

Conditions

Thoracic Aortic Disease

Outcome Measures

Primary Outcomes (1)

  • Composite endpoint of neurologic and acute kidney injury

    The primary objective of this study is to determine whether mild hypothermia (32°C) during aortic hemiarch surgery using unilateral selective anterograde cerebral perfusion (uSACP), is superior to moderate hypothermia (26°C) in reducing the composite endpoint of neurologic and acute kidney injury.

    Up to 90 days after surgery.

Secondary Outcomes (12)

  • Rates of Neurologic Injury

    Up to 90 days after surgery.

  • Incidence of Silent Strokes

    Up to 90 days after surgery.

  • Incidence of Acute Kidney Injury (AKI)

    Up to 90 days after surgery.

  • Incidence of Delirium

    Up to 90 days after surgery.

  • Death

    Up to 90 days after surgery.

  • +7 more secondary outcomes

Study Arms (2)

Mild Hypothermic Circulatory Arrest

EXPERIMENTAL

During aortic hemiarch surgery, mild hypothermia (32°C) will be used during circulatory arrest.

Procedure: Hypothermic circulatory arrest

Moderate Hypothermic Circulatory Arrest

ACTIVE COMPARATOR

During aortic hemiarch surgery, moderate hypothermia (26°C) will be used during circulatory arrest.

Procedure: Hypothermic circulatory arrest

Interventions

Hypothermic circulatory arrestPROCEDURE

During cardiac surgery requiring circulatory arrest, the patient's body temperature is lowered significantly to reduce the cellular metabolic rate and reduce ischemic injury.

Mild Hypothermic Circulatory ArrestModerate Hypothermic Circulatory Arrest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Elective aortic hemiarch surgery
  • Planned unilateral selective anterograde cardioplegia
  • Anticipated lower body arrest time of \< 20 minutes
  • Able to provide written informed consent

You may not qualify if:

  • Surgery for acute aortic dissection or emergent operations
  • Total arch replacement
  • Inability to perform unilateral selective anterograde cerebral perfusion (uSACP)
  • Patients with known/documented coagulopathy
  • Patients with cold agglutinin disease or those that test positive on routine preop screening
  • Pre-existing severe neurological impairment or inability to accurately assess neurocognitive function as determined by the operating surgeon
  • Severe carotid disease, defined as: any patient with previously documented carotid stenosis of \> 70% (via Doppler ultrasound (US), magnetic resonance angiography (MRA), or computer tomography angiography (CTA)) without neurological deficits; or carotid stenosis \> 50% with neurological deficits; or previous carotid endarterectomy or stenting
  • Patients in renal failure or currently being treated with renal replacement therapy (RRT) or estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2
  • Use of an investigational drug or device at time of enrollment
  • Participation in another clinical trial which interferes with performance of the study procedures or assessment of the outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Massachusetts General

Boston, Massachusetts, 02114, United States

RECRUITING

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

RECRUITING

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Kelowna General Hospital

Kelowna, British Columbia, V1Y 1T2, Canada

RECRUITING

Fraser Health Authority

Surrey, British Columbia, V3T 0H1, Canada

RECRUITING

University of British Columbia

Vancouver, British Columbia, V6Z 1Y6, Canada

NOT YET RECRUITING

Dalhousie university

Halifax, Nova Scotia, B3H 3A7, Canada

NOT YET RECRUITING

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Related Publications (1)

  • Jabagi H, Wells G, Boodhwani M. COMMENCE trial (Comparing hypOtherMic teMperaturEs duriNg hemiarCh surgEry): a randomized controlled trial of mild vs moderate hypothermia on patient outcomes in aortic hemiarch surgery with anterograde cerebral perfusion. Trials. 2019 Dec 9;20(1):691. doi: 10.1186/s13063-019-3713-9.

    PMID: 31815641DERIVED

MeSH Terms

Interventions

Circulatory Arrest, Deep Hypothermia Induced

Intervention Hierarchy (Ancestors)

Heart Arrest, InducedCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Munir Boodhwani, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jehangir Appoo, MD

CONTACT

403-944-2515jappoo@ucalgary.ca

Alice Black, BSc

CONTACT

613-696-7230alblack@ottawaheart.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 9, 2016

Study Start

February 20, 2018

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

September 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made available to other researchers.

Locations

US(3)CA(9)