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Completed

NCT Number: NCT04214145

The Effect of Vasopressors on Cerebral Oxygentaion During Off Pump CABG

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.

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Key information

Conditions

Cerebral Oxygen Saturation

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phenylephrine

Drug

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

Drug

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

Drug

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)

Primary outcomes

  1. Cerebral oxygen saturation (%)

    Time frame: during surgery

    continuous monitoring of cerebral oxygen saturation during surgery

Secondary outcomes

  1. blood pressure

    Time frame: during surgery

    systolic/diastolic/mean blood pressure(mmHg)

  2. heart rate

    Time frame: during surgery

    heart rate(/min)

  3. cardiac index

    Time frame: during surgery

    cardiac index (L/min)

  4. Total amount of infused drug

    Time frame: during surgery

    Propofol, remifentanil, vasoacitve drugs

  5. Input/output

    Time frame: during surgery

    Urine output, blood loss, amount of fluid and transfusion

  6. Sublingual microscopy

    Time frame: 1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure

    using SDF imaging device

  7. Vascular occlusion test

    Time frame: 1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure

    using InspectraTM StO2

  8. Troponin I

    Time frame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission

    Troponin I (ng/mL)

  9. lactate

    Time frame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission

    lactate (mmol/L)

  10. creatinine

    Time frame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission

    creatinine (mg/dL)

  11. albumin

    Time frame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission

    albumin (g/dL)

  12. NGAL

    Time frame: during surgery, at ICU admission, 24 hours / 48 hours after ICU admission

    NGAL (ng/mL)

  13. MACCE

    Time frame: until 1 year after surgery

    Major adverse cardiac and cerebrovascular events

  14. AKI/RRT

    Time frame: until 1 year after surgery

    renal complication

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 2, 2020
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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