The Effect of Vasopressors on Cerebral Oxygentaion During Off Pump CABG

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04214145

Collaborator

(none)

Enrollment

Location

Arms

19.9

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Oxygen Saturation	Drug: Phenylephrine Drug: Norepinephrine Drug: Vasopressin	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of Phenylephrine, Norepinephrine and Vasopressin on Cerebral Oxygentaion During Off Pump CABG: A Pilot Study

Actual Study Start Date :

Jan 7, 2020

Actual Primary Completion Date :

Sep 2, 2021

Actual Study Completion Date :

Sep 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phenylephrine	Drug: Phenylephrine Continuous infusion of Phenylenphrine 250 μg/mL (=Phenylephrine 10mg * 5@ + D5W 200 mL) if mean BP < 60mmHg. Initial rate: 0.42 μg/kg/min (=0.1 mL/kg/hr) Increment by 0.21 μg/kg/min (=0.05 mL/kg/hr) if mean BP < 60mmHg after 5 minutes Maximum rate: 3.33 μg/kg/min (=0.8 mL/kg/hr)
Experimental: Norepinephrine	Drug: Norepinephrine Continuous infusion of Norepienphrine 20 μg/mL (=NE 4mg * 1@ + D5W 200 mL) if mean BP < 60mmHg. Initial rate: 0.03 μg/kg/min (=0.1 mL/kg/hr) Increment by 0.015 μg/kg/min (=0.05 mL/kg/hr) if mean BP < 60mmHg after 5 minutes Maximum rate: 0.24 μg/kg/min (=0.8 mL/kg/hr)
Experimental: Vasopressin	Drug: Vasopressin Continuous infusion of Vasopressin 0.1 u/mL (=Vasopressin 20u * 1@ + D5W 200 mL) if mean BP < 60mmHg. Initial rate: 0.01 u/kg/hr (=0.1 mL/kg/hr) Increment by 0.005 u/kg/hr (=0.05 mL/kg/hr) if mean BP < 60mmHg after 5 minutes Maximum rate: 0.08 u/kg/hr (=0.8 mL/kg/hr)

Arm

Intervention/Treatment

Experimental: Phenylephrine

Drug: Phenylephrine

Continuous infusion of Phenylenphrine 250 μg/mL (=Phenylephrine 10mg * 5@ + D5W 200 mL) if mean BP < 60mmHg. Initial rate: 0.42 μg/kg/min (=0.1 mL/kg/hr) Increment by 0.21 μg/kg/min (=0.05 mL/kg/hr) if mean BP < 60mmHg after 5 minutes Maximum rate: 3.33 μg/kg/min (=0.8 mL/kg/hr)

Experimental: Norepinephrine

Drug: Norepinephrine

Continuous infusion of Norepienphrine 20 μg/mL (=NE 4mg * 1@ + D5W 200 mL) if mean BP < 60mmHg. Initial rate: 0.03 μg/kg/min (=0.1 mL/kg/hr) Increment by 0.015 μg/kg/min (=0.05 mL/kg/hr) if mean BP < 60mmHg after 5 minutes Maximum rate: 0.24 μg/kg/min (=0.8 mL/kg/hr)

Experimental: Vasopressin

Drug: Vasopressin

Continuous infusion of Vasopressin 0.1 u/mL (=Vasopressin 20u * 1@ + D5W 200 mL) if mean BP < 60mmHg. Initial rate: 0.01 u/kg/hr (=0.1 mL/kg/hr) Increment by 0.005 u/kg/hr (=0.05 mL/kg/hr) if mean BP < 60mmHg after 5 minutes Maximum rate: 0.08 u/kg/hr (=0.8 mL/kg/hr)

Outcome Measures

Primary Outcome Measures

Cerebral oxygen saturation (%) [during surgery]
continuous monitoring of cerebral oxygen saturation during surgery

Secondary Outcome Measures

blood pressure [during surgery]
systolic/diastolic/mean blood pressure(mmHg)
heart rate [during surgery]
heart rate(/min)
cardiac index [during surgery]
cardiac index (L/min)
Total amount of infused drug [during surgery]
Propofol, remifentanil, vasoacitve drugs
Input/output [during surgery]
Urine output, blood loss, amount of fluid and transfusion
Sublingual microscopy [1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure]
using SDF imaging device
Vascular occlusion test [1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure]
using InspectraTM StO2
Troponin I [during surgery, at ICU admission, 24 hours / 48 hours after ICU admission]
Troponin I (ng/mL)
lactate [during surgery, at ICU admission, 24 hours / 48 hours after ICU admission]
lactate (mmol/L)
creatinine [during surgery, at ICU admission, 24 hours / 48 hours after ICU admission]
creatinine (mg/dL)
albumin [during surgery, at ICU admission, 24 hours / 48 hours after ICU admission]
albumin (g/dL)
NGAL [during surgery, at ICU admission, 24 hours / 48 hours after ICU admission]
NGAL (ng/mL)
MACCE [until 1 year after surgery]
Major adverse cardiac and cerebrovascular events
AKI/RRT [until 1 year after surgery]
renal complication

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yunseok Jeon, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT04214145

Other Study ID Numbers:

OPCAB_vasopressor

First Posted:

Jan 2, 2020

Last Update Posted:

May 9, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2022