- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04214145
The Effect of Vasopressors on Cerebral Oxygentaion During Off Pump CABG
May 6, 2022 updated by: Yunseok Jeon, Seoul National University Hospital
The Effect of Phenylephrine, Norepinephrine and Vasopressin on Cerebral Oxygentaion During Off Pump CABG: A Pilot Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 03080
- Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients undergoing off pump coronary artery bypass.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phenylephrine
|
Continuous infusion of Phenylenphrine 250 μg/mL (=Phenylephrine 10mg * 5@ + D5W 200 mL) if mean BP < 60mmHg.
|
Experimental: Norepinephrine
|
Continuous infusion of Norepienphrine 20 μg/mL (=NE 4mg * 1@ + D5W 200 mL) if mean BP < 60mmHg.
|
Experimental: Vasopressin
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Continuous infusion of Vasopressin 0.1 u/mL (=Vasopressin 20u * 1@ + D5W 200 mL) if mean BP < 60mmHg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral oxygen saturation (%)
Time Frame: during surgery
|
continuous monitoring of cerebral oxygen saturation during surgery
|
during surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood pressure
Time Frame: during surgery
|
systolic/diastolic/mean blood pressure(mmHg)
|
during surgery
|
heart rate
Time Frame: during surgery
|
heart rate(/min)
|
during surgery
|
cardiac index
Time Frame: during surgery
|
cardiac index (L/min)
|
during surgery
|
Total amount of infused drug
Time Frame: during surgery
|
Propofol, remifentanil, vasoacitve drugs
|
during surgery
|
Input/output
Time Frame: during surgery
|
Urine output, blood loss, amount of fluid and transfusion
|
during surgery
|
Sublingual microscopy
Time Frame: 1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure
|
using SDF imaging device
|
1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure
|
Vascular occlusion test
Time Frame: 1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure
|
using InspectraTM StO2
|
1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure
|
Troponin I
Time Frame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
|
Troponin I (ng/mL)
|
during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
|
lactate
Time Frame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
|
lactate (mmol/L)
|
during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
|
creatinine
Time Frame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
|
creatinine (mg/dL)
|
during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
|
albumin
Time Frame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
|
albumin (g/dL)
|
during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
|
NGAL
Time Frame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
|
NGAL (ng/mL)
|
during surgery, at ICU admission, 24 hours / 48 hours after ICU admission
|
MACCE
Time Frame: until 1 year after surgery
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Major adverse cardiac and cerebrovascular events
|
until 1 year after surgery
|
AKI/RRT
Time Frame: until 1 year after surgery
|
renal complication
|
until 1 year after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 7, 2020
Primary Completion (Actual)
September 2, 2021
Study Completion (Actual)
September 3, 2021
Study Registration Dates
First Submitted
December 22, 2019
First Submitted That Met QC Criteria
December 26, 2019
First Posted (Actual)
January 2, 2020
Study Record Updates
Last Update Posted (Actual)
May 9, 2022
Last Update Submitted That Met QC Criteria
May 6, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Natriuretic Agents
- Cardiotonic Agents
- Respiratory System Agents
- Hemostatics
- Coagulants
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Antidiuretic Agents
- Adrenergic alpha-1 Receptor Agonists
- Norepinephrine
- Vasopressins
- Arginine Vasopressin
- Phenylephrine
- Oxymetazoline
Other Study ID Numbers
- OPCAB_vasopressor
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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