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

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.

  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)
Experimental: Norepinephrine

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)
Experimental: Vasopressin

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)

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
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

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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