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Comparing Hypothermic Temperatures During Hemiarch Surgery (TITAN:COMMENCE)

Primary Purpose

Thoracic Aortic Disease

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Hypothermic circulatory arrest
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Aortic Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • The Valley Hospital
  • Ohio State University Medical Center
  • Fraser Health AuthorityRecruiting
  • University of British Columbia
  • University of Manitoba
  • Dalhousie university
  • London Health Sciences CentreRecruiting
  • University of Ottawa Heart InstituteRecruiting
  • Montreal Heart Institute
  • Institut universitaire de cardiologie et de pneumologie de QuébecRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mild Hypothermic Circulatory Arrest

Moderate Hypothermic Circulatory Arrest

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rates of Neurologic Injury
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to incidence of neurologic injury, including transient ischemic attack (TIA) and permanent neurological dysfunction (PND) or stroke.
Incidence of Silent Strokes
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of silent strokes, defined as infarctions identified during magnetic resonance imaging (MRI) in patients without neurologic symptoms.
Incidence of Acute Kidney Injury (AKI)
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of acute kidney injury (AKI), defined as Stage 1 or greater using the KDIGO criteria. Using the KDIGO criteria, Stage 1 AKI is defined as an increase in serum creatinine of 1.5-1.9x the baseline or an increase >= 27umol/L with urine output <0.5mL/kg/hour for 6-12 hours.
Incidence of Delirium
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of delirium, using the Confusion Assessment Method (CAM). The Confusion Assessment Method defines delirium as the presence of acute changes in mental status with fluctuating course, plus inattention and the presence of either disorganized thinking OR altered level of consciousness.
Death
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of death
Evaluate differences in the duration of cardiopulmonary bypass used in patients who receive mild or moderate hypothermic circulatory arrest during aortic hemiarch surgery
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the length of time that the patient remains on cardiopulmonary bypass.
Rates of Mediastinal re-exploration for bleeding
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the rates of mediastinal re-exploration (re-operation) for bleeding.
Incidence and quantity of perioperative blood transfusions
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the number and quantity of perioperative blood transfusions
Incidence of prolonged Mechanical Ventilation
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the duration of mechanical ventilation. Mechanical ventilation will be defined as use of a mechanical ventilator ≥48 hours.
Perioperative Myocardial Infarction
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of perioperative myocardial infarction. This will be clinically diagnosed using a combination of electrocardiographic (new Q wave on 12 lead ECG) and/or biochemical (TnI > 45 ng/L) markers.
Length of Stay
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the duration of a patient's stay in the intensive care unit and on the hospital ward.
Quality of life (SF-12)
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the patient's quality of life measured using the Short Form (SF) 12 questionnaire.

Full Information

First Posted
August 4, 2016
Last Updated
May 5, 2023
Sponsor
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02860364
Brief Title
Comparing Hypothermic Temperatures During Hemiarch Surgery
Acronym
TITAN:COMMENCE
Official Title
A Randomized Controlled Trial of Mild vs. Moderate Hypothermia on Patient Outcomes in Aortic Hemiarch Surgery With Anterograde Cerebral Perfusion
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Heart Institute Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Aortic Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
282 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mild Hypothermic Circulatory Arrest
Arm Type
Experimental
Arm Description
During aortic hemiarch surgery, mild hypothermia (32°C) will be used during circulatory arrest.
Arm Title
Moderate Hypothermic Circulatory Arrest
Arm Type
Active Comparator
Arm Description
During aortic hemiarch surgery, moderate hypothermia (26°C) will be used during circulatory arrest.
Intervention Type
Procedure
Intervention Name(s)
Hypothermic circulatory arrest
Intervention Description
During cardiac surgery requiring circulatory arrest, the patient's body temperature is lowered significantly to reduce the cellular metabolic rate and reduce ischemic injury.
Primary Outcome Measure Information:
Title
Composite endpoint of neurologic and acute kidney injury
Description
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.
Time Frame
Up to 90 days after surgery.
Secondary Outcome Measure Information:
Title
Rates of Neurologic Injury
Description
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to incidence of neurologic injury, including transient ischemic attack (TIA) and permanent neurological dysfunction (PND) or stroke.
Time Frame
Up to 90 days after surgery.
Title
Incidence of Silent Strokes
Description
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of silent strokes, defined as infarctions identified during magnetic resonance imaging (MRI) in patients without neurologic symptoms.
Time Frame
Up to 90 days after surgery.
Title
Incidence of Acute Kidney Injury (AKI)
Description
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of acute kidney injury (AKI), defined as Stage 1 or greater using the KDIGO criteria. Using the KDIGO criteria, Stage 1 AKI is defined as an increase in serum creatinine of 1.5-1.9x the baseline or an increase >= 27umol/L with urine output <0.5mL/kg/hour for 6-12 hours.
Time Frame
Up to 90 days after surgery.
Title
Incidence of Delirium
Description
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of delirium, using the Confusion Assessment Method (CAM). The Confusion Assessment Method defines delirium as the presence of acute changes in mental status with fluctuating course, plus inattention and the presence of either disorganized thinking OR altered level of consciousness.
Time Frame
Up to 90 days after surgery.
Title
Death
Description
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of death
Time Frame
Up to 90 days after surgery.
Title
Evaluate differences in the duration of cardiopulmonary bypass used in patients who receive mild or moderate hypothermic circulatory arrest during aortic hemiarch surgery
Description
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the length of time that the patient remains on cardiopulmonary bypass.
Time Frame
During the index procedure
Title
Rates of Mediastinal re-exploration for bleeding
Description
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the rates of mediastinal re-exploration (re-operation) for bleeding.
Time Frame
Up to 90 days after surgery.
Title
Incidence and quantity of perioperative blood transfusions
Description
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the number and quantity of perioperative blood transfusions
Time Frame
Up to 90 days after surgery.
Title
Incidence of prolonged Mechanical Ventilation
Description
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the duration of mechanical ventilation. Mechanical ventilation will be defined as use of a mechanical ventilator ≥48 hours.
Time Frame
Up to 90 days after surgery.
Title
Perioperative Myocardial Infarction
Description
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the incidence of perioperative myocardial infarction. This will be clinically diagnosed using a combination of electrocardiographic (new Q wave on 12 lead ECG) and/or biochemical (TnI > 45 ng/L) markers.
Time Frame
Up to 48 hours after surgery.
Title
Length of Stay
Description
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the duration of a patient's stay in the intensive care unit and on the hospital ward.
Time Frame
Up to 90 days after surgery.
Title
Quality of life (SF-12)
Description
Comparison of mild (32°C) vs moderate (26°C) hypothermia in aortic hemiarch surgery with respect to the patient's quality of life measured using the Short Form (SF) 12 questionnaire.
Time Frame
Up to 90 days after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jehangir Appoo, MD
Phone
403-944-2515
Email
jappoo@ucalgary.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Zhang, MD, PhD
Phone
613-696-7230
Email
mzhang@ottawaheart.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Munir Boodhwani, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New York
ZIP/Postal Code
07652
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Grau, MD
First Name & Middle Initial & Last Name & Degree
Jabagi Habib, MD
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jovan Bovinovski, MD
Facility Name
Fraser Health Authority
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3T 0H1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Wong, MD
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joel Price, MD
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Yamashita, MD
Facility Name
Dalhousie university
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Herman, MD
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Chu, MD
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Munir Boodhwani
Facility Name
Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Demers
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francois Dagenais, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be made available to other researchers.
Citations:
PubMed Identifier
31815641
Citation
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.
Results Reference
derived

Learn more about this trial

Comparing Hypothermic Temperatures During Hemiarch Surgery

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