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Cognition DisordersNCT02834065

Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest

A study testing Cardiopulmonary bypass machine in people with Cognition Disorders, run by Duke University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cognition Disorders
What is being tested?
Cardiopulmonary bypass machine
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
273 participants
Where
4 sitesUnited States
Study dates
28 Jul 2016to Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • < 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)
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  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • Duke University Health System

    Durham, North Carolina, 27710

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • Baylor Scott & White Research Institute

    Plano, Texas, 75093

Other trials in United States

About this study

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.

Read the detailed description

Purpose of the Study: Determine the effect of deep vs low vs moderate hypothermia on neurocognitive function, brain functional connectivity, and leukocyte SUMOylation patterns after surgical circulatory arrest.

Hypothesis: Deep hypothermia is superior to moderate hypothermia in reducing postoperative cognitive decline and preserving brain functional connectivity and that low hypothermia is non-inferior to deep hypothermia.

Design and Procedures: 273 informed and consenting 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 will be randomized to deep (<20°C), low (20.1°C-24°C), or moderate (24.1°C-28°C) hypothermia during circulatory arrest. Cognitive testing using a standard battery will occur preoperatively (baseline), at 4 weeks, and at 1 year after surgery. Neuroimaging procedures before surgery, and at 4 weeks and 1 year after surgery will consist of high-resolution anatomic, resting-state fMRI (rs-fMRI) and magnetic resonance spectroscopy (MRS) sequences. To characterize leukocyte activation, whole blood will be drawn at 5 time points: at baseline (prior to surgery), before circulatory arrest, 10 minutes after reperfusion, 10 minutes after CPB, and 4 hours after CPB.

Being tested
Cardiopulmonary bypass machine
Keywords
Postoperative Cognitive Decline, Deep Hypothermic Circulatory Arrest, Cardiovascular Surgical Procedures, Functional Magnetic Resonance Imaging, Small Ubiquitin-Related Modifier Proteins
Medical subject headings
Cognition Disorders, Postoperative Cognitive Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiopulmonary bypass machineDevice

    Routinely used cardiopulmonary bypass machine (standard of care) will be used to initiate circulatory arrest

Study groups in NCT02834065
Study groupRoleWhat they receive
Deep HypothermiaActive comparatorInitiation of circulatory arrest using the cardiopulmonary bypass machine at temperature ≤20 degrees Celsius
Receives: Device: Cardiopulmonary bypass machine
Low HypothermiaActive comparatorInitiation of circulatory arrest using the cardiopulmonary bypass machine at temperature 20.1 - 24.0 degrees Celsius
Receives: Device: Cardiopulmonary bypass machine
Moderate HypothermiaActive comparatorInitiation of circulatory arrest using the cardiopulmonary bypass machine at temperature 24.1 - 28 degrees Celsius
Receives: Device: Cardiopulmonary bypass machine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From baseline to 4 weeks post-operatively

Secondary outcomes (11)

  1. Change in SUMO 2/3 levels

    Measured: Pre-incision, before circulatory arrest, 10 minutes after reperfusion, 10 minutes after cardiopulmonary bypass, 4 hrs after cardiopulmonary bypass

  2. Change in long-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 1 year.

    Measured: From baseline to 1 year post-operatively

  3. Incidence of delirium

    Confusion Assessment Method (CAM)

    Measured: Up to post-operative day 3

  4. Change in neurological function as measured by NIHSS

    Measured: Assessed at baseline, post-op day 4, 4 weeks

  5. Change in neuronal metabolism

    Magnetic resonance spectra (metabolic peaks) of myoinositol, creatine, choline and N-acetyl aspartate

    Measured: From baseline to 4 weeks

  6. Change in resting-state functional connectivity

    For the rs-fMRI data, the analyses of primary interest will be the spontaneous, low-frequency fluctuations in the blood oxygen level dependent (BOLD) data of the Default Mode, Salience, and Executive Control Networks.

    Measured: From baseline to 4 weeks post-operatively

  7. Change in Duke Activity Status Index score

    Measured: From baseline to 4 weeks postoperatively

  8. Change in depression score

    Measured by the Center for Epidemiological Studies Depression Scale (CES-D).

    Measured: From baseline to 4 weeks postoperatively

  9. Change in anxiety score

    Measured by State Trait Anxiety Inventory (STA-I).

    Measured: From baseline to 4 weeks postoperatively

  10. Change in SF-36 score

    Measured: From baseline to 1 year postoperatively

  11. Change in employment status

    Measured: From baseline to 1 year postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2016 (estimated)
  2. Study start28 Jul 2016
  3. Primary completionJan 2022
  4. Study completionFeb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
273 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02834065
Sponsor's protocol ID
Pro00064962
Other IDs
1R01HL130443-01A1
Status last verified
Feb 2023
First submitted
6 Jul 2016
Last updated
24 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38084590

Questions about this trial

What is this clinical trial studying?

A study testing Cardiopulmonary bypass machine in people with Cognition Disorders, run by Duke University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in short-term cognition as measured by continuous cognitive score (time frame: From baseline to 4 weeks post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02834065, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.

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