Cerebral DesaturationCOASTLINENCT03215589
Assessment of Cerebral Blood Flow Asymmetry in Cardiac Surgery Patients Undergoing Hypothermic Circulatory Arrest
An observational study of Cerebral Desaturation and Cerebral Ischemia, run by University of Manitoba at 1 site in Canada.
Trial summary
Cerebral oxygen desaturation during cardiac surgery measured using near infrared spectroscopy (NIRS) derived cerebral oximetry has been associated with significant postoperative morbidity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Desaturation, Cerebral Ischemia
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jul 2017to 31 Dec 2018
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: A convenience sample of 20 consecutive patients undergoing cardiac surgery employing CPB will be studied
Who may be able to join
- Informed consent
- Age 18 years or older
- Surgery requiring cardio pulmonary bypass
- Ascending aorta or arch repair surgery
- Surgery requiring hypothermic circulatory arrest
Who cannot join
- Off-pump cardiac surgery
- Skin condition preventing the use of cerebral oximetry pads
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cerebral Desaturation, Cerebral Ischemia
- Keywords
- Near-infrared spectroscopy-derived cerebral oximetry
- Medical subject headings
- Brain Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of hypothermic circulatory arrest between surgical induction and ICU admission
Secondary outcomes (18)
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.
Measured: 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.
Measured: Duration of hypothermic circulatory arrest between surgical induction and ICU admission
All cause mortality
All cause mortality
Measured: Surgical induction to 30 day postoperative
Neurologic injury
Any neurologic injury, including: stroke, delirium, seizures, coma
Measured: 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
Measured: Surgical induction to 30 day postoperative
Serious infection
Serious infection including: mediastinitis, cellulitis, pneumonia, urinary tract infection
Measured: Surgical induction to 30 day postoperative
Gastrointestinal morbidity
Gastrointestinal (GI) morbidity defined as GI bleed, bowel perforation and/or ischemia
Measured: Surgical induction to 30 day postoperative
In-hospital mortality
In hospital mortality
Measured: 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
Measured: Surgical induction to hospital discharge or 30 days postoperative, whichever comes first
ICU length of stay
length of stay in the intensive care unit
Measured: 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
Measured: Time of surgical intubation to time of extubation
Transfusions
The need for transfusions, including: red blood cells, platelets, plasma and cryoprecipitate
Measured: 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
Measured: 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
Measured: ICU admission to hospital discharge or 30 days postoperative, whichever comes first
Atrial fibrillation
Atrial fibrillation
Measured: ICU admission to hospital discharge or 30 days postoperative, whichever comes first
Myocardial infarction
Myocardial infarction as defined by:
Measured: 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
Measured: 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
Measured: ICU admission to hospital discharge or 30 days postoperative, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start3 Jul 2017
- Primary completion3 Jul 2018
- Study completion31 Dec 2018
Why it stopped: due to a change in surgical personnel, the operative technique changed, precluding the examination of bypass-related bi-hemispheric saturation differences.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral DesaturationStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hilary P Grocott, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215589
- Sponsor's protocol ID
- B2017:002
- Acronym
- COASTLINE
- Status last verified
- Jun 2018
- First submitted
- 4 Jul 2017
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 17179242Fischer 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.
PubMed 20579669
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03215589
- Acronym / sponsor ID
- COASTLINE / B2017:002
- Conditions
- Cerebral Desaturation, Cerebral Ischemia
- Keywords
- Near-infrared spectroscopy-derived cerebral oximetry
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to a change in surgical personnel, the operative technique changed, precluding the examination of bypass-related bi-hemispheric saturation differences.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 3 Jul 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A convenience sample of 20 consecutive patients undergoing cardiac surgery employing CPB will be studied
Key inclusion criteria (5 listed)
- Informed consent
- Age 18 years or older
- Surgery requiring cardio pulmonary bypass
- Ascending aorta or arch repair surgery
- Surgery requiring hypothermic circulatory arrest
Key exclusion criteria (2 listed)
- Off-pump cardiac surgery
- Skin condition preventing the use of cerebral oximetry pads
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
18 secondary outcomes
Severity of asymmetrical cerebral desaturation
Time frame: 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
All cause mortality
Time frame: Surgical induction to 30 day postoperative
Neurologic injury
Time frame: Surgical induction to 30 day postoperative
Renal injury
Time frame: Surgical induction to 30 day postoperative
Serious infection
Time frame: Surgical induction to 30 day postoperative
Gastrointestinal morbidity
Time frame: Surgical induction to 30 day postoperative
In-hospital mortality
Time frame: 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
ICU length of stay
Time frame: ICU admission to ICU discharge or 30 days postoperative, whichever comes first
Intubation time
Time frame: Time of surgical intubation to time of extubation
Transfusions
Time frame: 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
Hemostatic support
Time frame: 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
Myocardial infarction
Time frame: 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
Nausea and vomiting
Time frame: ICU admission to hospital discharge or 30 days postoperative, whichever comes first
Results and safety
The study was stopped early (reason given: due to a change in surgical personnel, the operative technique changed, precluding the examination of bypass-related bi-hemispheric saturation differences.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Background: PubMed 17179242Murkin 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.
- Background: PubMed 20579669Fischer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilary P Grocott, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Desaturation and Cerebral Ischemia, run by University of Manitoba at 1 site in Canada.
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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 was stopped early (reason given: due to a change in surgical personnel, the operative technique changed, precluding the examination of bypass-related bi-hemispheric saturation differences.). Results are not available in the source record.
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?
Incidence of asymmetrical cerebral desaturation (time frame: Duration of hypothermic circulatory arrest between surgical induction and ICU admission). 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 NCT03215589, which also lists 2 linked publications.
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 17 Feb 2020.