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

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: Terminated
• Conditions: Cerebral Ischemia; Cerebral Desaturation

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: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of asymmetrical cerebral desaturation	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

Outcome Measure	Measure Description	Time Frame
Severity of asymmetrical cerebral desaturation	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 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	All cause mortality	Surgical induction to 30 day postoperative
Neurologic injury	Any neurologic injury, including: stroke, delirium, seizures, coma	Surgical induction to 30 day postoperative
Renal injury	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	Serious infection including: mediastinitis, cellulitis, pneumonia, urinary tract infection	Surgical induction to 30 day postoperative
Gastrointestinal morbidity	Gastrointestinal (GI) morbidity defined as GI bleed, bowel perforation and/or ischemia	Surgical induction to 30 day postoperative
In-hospital mortality	In hospital mortality	Surgical induction to hospital discharge or 30 days postoperative, whichever comes first
Hospital length of stay	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	length of stay in the intensive care unit	ICU admission to ICU discharge or 30 days postoperative, whichever comes first
Intubation time	Duration of time that the patient was intubation from the start of surgery	Time of surgical intubation to time of extubation
Transfusions	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	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	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	Atrial fibrillation	ICU admission to hospital discharge or 30 days postoperative, whichever comes first
Myocardial infarction	Myocardial infarction as defined by:	ICU admission to hospital discharge or 30 days postoperative, whichever comes first
Atrial and/or ventricular arrhythmia	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	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

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Hilary P Grocott, MD, University of Manitoba

Publications and helpful links

General Publications

• Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.
• Fischer GW, Lin HM, Krol M, Galati MF, Di Luozzo G, Griepp RB, Reich DL. Noninvasive cerebral oxygenation may predict outcome in patients undergoing aortic arch surgery. J Thorac Cardiovasc Surg. 2011 Mar;141(3):815-21. doi: 10.1016/j.jtcvs.2010.05.017. Epub 2010 Jun 25.

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2017
• Primary Completion (Actual): July 3, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: July 4, 2017
• First Submitted That Met QC Criteria: July 10, 2017
• First Posted (Actual): July 12, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Near-infrared spectroscopy-derived cerebral oximetry
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infarction; Stroke; Brain Infarction; Brain Ischemia; Ischemia; Cerebral Infarction
• Other Study ID 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