Cerebral Ischemia Clinical Trial
— COASTLINEOfficial 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
NCT number | NCT03215589 |
Other study ID # | B2017:002 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | July 3, 2017 |
Est. completion date | December 31, 2018 |
Verified date | June 2018 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | St. Boniface Hospital | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba |
Canada,
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
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 |
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