Assessment of Cerebral Blood Flow Asymmetry in Cardiac Surgery Patients Undergoing Hypothermic Circulatory Arrest (COASTLINE)

February 12, 2020 updated by: University of Manitoba

A Prospective Study of Cerebral Oximetry to Assess Symmetry of Cerebral Blood Flow and Clinical Outcomes in Cardiac Surgery Patients Undergoing Hypothermic Circulatory Arrest

Cerebral oxygen desaturation during cardiac surgery measured using near infrared spectroscopy (NIRS) derived cerebral oximetry has been associated with significant postoperative morbidity. If significant desaturation occurs during this period, it may represent an ideal opportunity to further optimize the postoperative care of these patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Selective antegrade cerebral perfusion (SACP) is a commonly used technique for maintaining cerebral blood flow (CBF) during the use of hypothermic cardiac arrest (HCA) for aortic arch reconstruction. However, even with an intact Circle of Willis, asymmetric CBF is a common occurrence during HCA when SACP is used. The investigators have previously shown that ultrasound guided extrinsic compression of the left carotid artery can increase left cerebral oxygen saturation, and improved symmetry of CBF; however, this has not been investigated formally. In this study, the investigators will firstly formally assess the incidence and severity of asymmetrical cerebral flow between the left and right hemispheres in patients undergoing aortic arch repair (n=20). CBF will be assessed indirectly through regional cerebral oxygen saturation (rSO2) measured via near-infrared spectroscopy-derived cerebral oximetry. In addition, a number of clinical outcome parameters (up to 30 days post-op) will be evaluated. The investigators expect that significant left-side cerebral hypoperfusion will consistently be observed in patients undergoing aortic arch repair using SACP.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H2A6
        • St. Boniface Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A convenience sample of 20 consecutive patients undergoing cardiac surgery employing CPB will be studied

Description

Inclusion Criteria:

  • Informed consent
  • Age 18 years or older
  • Surgery requiring cardio pulmonary bypass
  • Ascending aorta or arch repair surgery
  • Surgery requiring hypothermic circulatory arrest

Exclusion Criteria:

  • Off-pump cardiac surgery
  • Skin condition preventing the use of cerebral oximetry pads

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of asymmetrical cerebral desaturation
Time Frame: Duration of hypothermic circulatory arrest between surgical induction and ICU admission
Cerebral desaturation defined as a greater than 10% difference in cerebral saturation comparing one hemisphere to the other based on a baseline reading taken in the minute preceding the onset of HCA to the end of the hypothermic period.
Duration of hypothermic circulatory arrest between surgical induction and ICU admission

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severity of asymmetrical cerebral desaturation
Time Frame: Duration of hypothermic circulatory arrest between surgical induction and ICU admission
Area of the curve (AUC) and time under the curve (TUC) for all saturation events less than pre-induction baseline as well as for 10%, 15% and 25%, relative reductions under the baseline rSO2 will also be determined. In addition, the AUC and TUC for rSO2 less than an absolute rSO2 of 50% will also be determined.
Duration of hypothermic circulatory arrest between surgical induction and ICU admission
Severity of asymmetrical cerebral desaturation
Time Frame: Duration of hypothermic circulatory arrest between surgical induction and ICU admission
Time under the curve (TUC) for all saturation events less than pre-induction baseline as well as for 10%, 15% and 25%, relative reductions under the baseline rSO2 will also be determined. In addition, the AUC and TUC for rSO2 less than an absolute rSO2 of 50% will also be determined.
Duration of hypothermic circulatory arrest between surgical induction and ICU admission
All cause mortality
Time Frame: Surgical induction to 30 day postoperative
All cause mortality
Surgical induction to 30 day postoperative
Neurologic injury
Time Frame: Surgical induction to 30 day postoperative
Any neurologic injury, including: stroke, delirium, seizures, coma
Surgical induction to 30 day postoperative
Renal injury
Time Frame: Surgical induction to 30 day postoperative
Renal injury defined as a 50% decrease in estimated glomerular filtration rate (GFR) and/or need for dialysis
Surgical induction to 30 day postoperative
Serious infection
Time Frame: Surgical induction to 30 day postoperative
Serious infection including: mediastinitis, cellulitis, pneumonia, urinary tract infection
Surgical induction to 30 day postoperative
Gastrointestinal morbidity
Time Frame: Surgical induction to 30 day postoperative
Gastrointestinal (GI) morbidity defined as GI bleed, bowel perforation and/or ischemia
Surgical induction to 30 day postoperative
In-hospital mortality
Time Frame: Surgical induction to hospital discharge or 30 days postoperative, whichever comes first
In hospital mortality
Surgical induction to hospital discharge or 30 days postoperative, whichever comes first
Hospital length of stay
Time Frame: Surgical induction to hospital discharge or 30 days postoperative, whichever comes first
The length of time (in days) that the patient remained in the hospital after surgery
Surgical induction to hospital discharge or 30 days postoperative, whichever comes first
ICU length of stay
Time Frame: ICU admission to ICU discharge or 30 days postoperative, whichever comes first
length of stay in the intensive care unit
ICU admission to ICU discharge or 30 days postoperative, whichever comes first
Intubation time
Time Frame: Time of surgical intubation to time of extubation
Duration of time that the patient was intubation from the start of surgery
Time of surgical intubation to time of extubation
Transfusions
Time Frame: Surgical induction to hospital discharge or 30 days postoperative, whichever comes first
The need for transfusions, including: red blood cells, platelets, plasma and cryoprecipitate
Surgical induction to hospital discharge or 30 days postoperative, whichever comes first
Renal function
Time Frame: Preoperative to hospital discharge or 30 days postoperative, whichever comes first
Greatest percent change in creatinine and 25% and 50% increase in creatinine
Preoperative to hospital discharge or 30 days postoperative, whichever comes first
Hemostatic support
Time Frame: ICU admission to hospital discharge or 30 days postoperative, whichever comes first
Requirement of vasopressors, intra-aortic balloon pumps (IABPs) and inotropes (0-12 hours, 12-24 hours and >24 hours post-operative
ICU admission to hospital discharge or 30 days postoperative, whichever comes first
Atrial fibrillation
Time Frame: ICU admission to hospital discharge or 30 days postoperative, whichever comes first
Atrial fibrillation
ICU admission to hospital discharge or 30 days postoperative, whichever comes first
Myocardial infarction
Time Frame: ICU admission to hospital discharge or 30 days postoperative, whichever comes first
Myocardial infarction as defined by:
ICU admission to hospital discharge or 30 days postoperative, whichever comes first
Atrial and/or ventricular arrhythmia
Time Frame: ICU admission to hospital discharge or 30 days postoperative, whichever comes first
Atrial and/or ventricular arrhythmia, requiring electrical or pharmacologic intervention
ICU admission to hospital discharge or 30 days postoperative, whichever comes first
Nausea and vomiting
Time Frame: ICU admission to hospital discharge or 30 days postoperative, whichever comes first
Excess nausea and vomiting, requiring more than one drug therapy
ICU admission to hospital discharge or 30 days postoperative, whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hilary P Grocott, MD, University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 3, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2017:002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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