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

Cerebral Ischemia Clinical Trial

— COASTLINE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03215589
• Other study ID #: B2017:002
• Status: Terminated
• Start date: July 3, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2018
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 31, 2018
• Est. primary completion date: July 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Desaturation
• Cerebral Infarction
• Cerebral Ischemia
• Ischemia

Locations

Country	Name	City	State
Canada	St. Boniface Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

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