Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest
2 other identifiers
interventional
273
1 country
4
Brief Summary
In this study the investigator will randomize 273 subjects to deep (\<20°C), low (20.1°C-24°C), or moderate (24.1°C-28°C) hypothermia during aortic arch surgery with circulatory arrest. The primary purpose of this study is to determine the effect of deep vs low vs moderate hypothermia on neurocognitive function, brain functional connectivity, and leukocyte SUMOylation patterns after surgical circulatory arrest in participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
4 active sites
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
First Submitted
Initial submission to the registry
July 6, 2016
CompletedFirst Posted
Study publicly available on registry
July 15, 2016
CompletedStudy Start
First participant enrolled
July 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedFebruary 24, 2023
February 1, 2023
5.4 years
July 6, 2016
February 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in short-term cognition as measured by continuous cognitive score
To characterize cognitive function over time while minimizing potential redundancy in the cognitive measures, a factor analysis will be performed on the cognitive test scores from baseline. A continuous change score will be calculated by subtracting the baseline cognitive index (the mean of the domain scores from factor analysis) from the follow-up cognitive index at 4 weeks.
From baseline to 4 weeks post-operatively
Secondary Outcomes (11)
Change in SUMO 2/3 levels
Pre-incision, before circulatory arrest, 10 minutes after reperfusion, 10 minutes after cardiopulmonary bypass, 4 hrs after cardiopulmonary bypass
Change in long-term cognition as measured by continuous cognitive score
From baseline to 1 year post-operatively
Incidence of delirium
Up to post-operative day 3
Change in neurological function as measured by NIHSS
Assessed at baseline, post-op day 4, 4 weeks
Change in neuronal metabolism
From baseline to 4 weeks
- +6 more secondary outcomes
Study Arms (3)
Deep Hypothermia
ACTIVE COMPARATORInitiation of circulatory arrest using the cardiopulmonary bypass machine at temperature ≤20 degrees Celsius
Low Hypothermia
ACTIVE COMPARATORInitiation of circulatory arrest using the cardiopulmonary bypass machine at temperature 20.1 - 24.0 degrees Celsius
Moderate Hypothermia
ACTIVE COMPARATORInitiation of circulatory arrest using the cardiopulmonary bypass machine at temperature 24.1 - 28 degrees Celsius
Interventions
Routinely used cardiopulmonary bypass machine (standard of care) will be used to initiate circulatory arrest
Eligibility Criteria
You may qualify if:
- Patients who are scheduled for elective proximal aortic reconstructive surgery (ascending aorta + aortic valve or root) with concomitant proximal hemi- or total arch replacement via median sternotomy
You may not qualify if:
- \< 18 years of age
- History of symptomatic cerebrovascular disease, eg, prior stroke with residual deficit
- Alcoholism (\> 2 drinks/day)
- Psychiatric illness (any clinical diagnoses requiring therapy)
- Drug abuse (any illicit drug use in the past 3 months)
- Hepatic insufficiency (liver function tests \> 1.5 times the upper limit of normal)
- Severe pulmonary insufficiency (requiring home oxygen therapy)
- Renal failure (serum creatinine \> 2.0 mg/dL)
- Claustrophobic fear
- Unable to read and thus unable to complete the cognitive testing
- Pregnant women
- Patients who score \< 24 on a baseline Mini Mental State Examination (MMSE) or ≥ 27 on the baseline Center for Epidemiological Studies Depression (CES-D) scale
- Patients who have pre-existing unsafe implants for 3 Tesla magnetic resonance imaging (MRI).
- Patients who have received chemotherapy in the last 12 months.
- Patients with COVID-19 diagnosis within the past 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Emory Healthcarecollaborator
- University of Pennsylvaniacollaborator
- National Institutes of Health (NIH)collaborator
- Baylor Scott and White Healthcollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (4)
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Duke University Health System
Durham, North Carolina, 27710, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Baylor Scott & White Research Institute
Plano, Texas, 75093, United States
Related Publications (1)
Hughes GC, Chen EP, Browndyke JN, Szeto WY, DiMaio JM, Brinkman WT, Gaca JG, Blumenthal JA, Karhausen JA, Bisanar T, James ML, Yanez D, Li YJ, Mathew JP. Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest Trial (GOT ICE): A Randomized Clinical Trial Comparing Outcomes After Aortic Arch Surgery. Circulation. 2024 Feb 27;149(9):658-668. doi: 10.1161/CIRCULATIONAHA.123.067022. Epub 2023 Dec 12.
PMID: 38084590DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph P Mathew, MD, MHSc, MBA
Duke Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2016
First Posted
July 15, 2016
Study Start
July 28, 2016
Primary Completion
January 1, 2022
Study Completion
February 1, 2023
Last Updated
February 24, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share