The Effect of Vasopressors on Cerebral Oxygentaion During Off Pump CABG

Cerebral Oxygen Saturation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04214145
• Other study ID #: OPCAB_vasopressor
• Status: Completed
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: September 3, 2021

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 3, 2021
• Est. primary completion date: September 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Oxygen Saturation

Intervention

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)
• 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)
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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