The Effect of Vasopressors on Cerebral Oxygentaion During Off Pump CABG
The Effect of Phenylephrine, Norepinephrine and Vasopressin on Cerebral Oxygentaion During Off Pump CABG: A Pilot Study
1 other identifier
interventional
90
1 country
1
Brief Summary
The purpose of this study is to analyze the changes in cerebral oxygen saturation during the use of three vasopressors, phenylephrine, norepinephrine, and vasopressin, which are currently used during coronary artery bypass grafting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2019
CompletedFirst Posted
Study publicly available on registry
January 2, 2020
CompletedStudy Start
First participant enrolled
January 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2021
CompletedMay 9, 2022
May 1, 2022
1.7 years
December 22, 2019
May 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Cerebral oxygen saturation (%)
continuous monitoring of cerebral oxygen saturation during surgery
during surgery
Secondary Outcomes (14)
blood pressure
during surgery
heart rate
during surgery
cardiac index
during surgery
Total amount of infused drug
during surgery
Input/output
during surgery
- +9 more secondary outcomes
Study Arms (3)
Phenylephrine
EXPERIMENTALNorepinephrine
EXPERIMENTALVasopressin
EXPERIMENTALInterventions
Continuous infusion of Phenylenphrine 250 μg/mL (=Phenylephrine 10mg \* 5@ + D5W 200 mL) if mean BP \< 60mmHg. 1. Initial rate: 0.42 μg/kg/min (=0.1 mL/kg/hr) 2. Increment by 0.21 μg/kg/min (=0.05 mL/kg/hr) if mean BP \< 60mmHg after 5 minutes 3. Maximum rate: 3.33 μg/kg/min (=0.8 mL/kg/hr)
Continuous infusion of Norepienphrine 20 μg/mL (=NE 4mg \* 1@ + D5W 200 mL) if mean BP \< 60mmHg. 1. Initial rate: 0.03 μg/kg/min (=0.1 mL/kg/hr) 2. Increment by 0.015 μg/kg/min (=0.05 mL/kg/hr) if mean BP \< 60mmHg after 5 minutes 3. Maximum rate: 0.24 μg/kg/min (=0.8 mL/kg/hr)
Continuous infusion of Vasopressin 0.1 u/mL (=Vasopressin 20u \* 1@ + D5W 200 mL) if mean BP \< 60mmHg. 1. Initial rate: 0.01 u/kg/hr (=0.1 mL/kg/hr) 2. Increment by 0.005 u/kg/hr (=0.05 mL/kg/hr) if mean BP \< 60mmHg after 5 minutes 3. Maximum rate: 0.08 u/kg/hr (=0.8 mL/kg/hr)
Eligibility Criteria
You may qualify if:
- Patients undergoing off pump coronary artery bypass.
You may not qualify if:
- Patient refusal
- Preoperative vasopressor use
- Preoperative mechanical circulatory support
- Concurrent cerebrovascular or head and neck surgery
- Technical difficulty of measuring brain oxygen saturation
- Redo coronary artery bypass surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
Seoul, 03080, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 22, 2019
First Posted
January 2, 2020
Study Start
January 7, 2020
Primary Completion
September 2, 2021
Study Completion
September 3, 2021
Last Updated
May 9, 2022
Record last verified: 2022-05