Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients

Overview

This study will evaluate if Hydroxocobalamin may be a new and possibly superior treatment for refractory vasoplegic syndrome during liver transplant surgery.

Full Title of Study: “The Efficacy of Intravenous Hydroxocobalamin Versus Methylene Blue as Treatment for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2024

Detailed Description

This randomized, prospective, open label, pilot study will involve 20 LT patients with intraoperative vasoplegic syndrome. If vasoplegic syndrome is identified via SVR lower than 500 dynes-sec/cm-5, the patients will be randomized to receiving either IV methylene blue or hydroxocobalamin (10 patients in each group). The primary end point will examine the efficacy of the two medications on treating intraoperative vasoplegic syndrome. The SVR, blood pressure, and amount of administered vasopressors at 0, 15, 30, 60, 90, 120, 150, and 180 minutes after the medication administrations will be recorded. .

Interventions

  • Drug: Hydroxocobalamin
    • Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
  • Drug: Methylene Blue
    • Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes

Arms, Groups and Cohorts

  • Experimental: Cyanokit
    • Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
  • Active Comparator: Methylene Blue
    • Single dose intraoperatively of Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes

Clinical Trial Outcome Measures

Primary Measures

  • Systemic Vascular Resistance (SVR)
    • Time Frame: Intraoperative period
    • Improving hemodynamic stability as measured by SVR
  • Blood pressure (BP)
    • Time Frame: Intraoperative period
    • Improving hemodynamic stability as measured by systemic blood pressure
  • Vasopressors
    • Time Frame: Intraoperative period
    • Improving hemodynamic stability as measured by amount of vasopressors administered.

Secondary Measures

  • Early tracheal extubation
    • Time Frame: up to 1 day after surgery
    • Patient outcomes in the postoperative period as measured by early tracheal extubation after surgery
  • Length of hospital and intensive care unit stay
    • Time Frame: Up to 30 days after surgery
    • Patient outcomes in the postoperative period as measured by length of hospital and intensive care unit stay
  • Perioperative complications
    • Time Frame: Up to 30 days after surgery
    • Patient outcomes in the postoperative period as measured by perioperative complications (stroke, myocardial infarction, and acute renal failure).
  • Graft function
    • Time Frame: Up to 1 year after surgery
    • Patient outcomes in the postoperative period as measured by graft function
  • Survival rate
    • Time Frame: Up to 1 year after surgery
    • Patient outcomes in the postoperative period as measured by survival rate

Participating in This Clinical Trial

  • Patients scheduled to undergo liver transplantation – Patients able to read and understand consent document (if patient is unable to provide an informed consent, the Legally Authorized Representative will be ask to consent on behalf of the patient). – SVR lower than 500 dynes-sec/cm-5 intraoperatively (this criterion must be met after consent intraoperatively)
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Mayo Clinic
    • Provider of Information About this Clinical Study
      • Principal Investigator: Sher-Lu Pai, Consultant in Anesthesia – Mayo Clinic
    • Overall Official(s)
      • Sher-Lu Pai, MD, Principal Investigator, Mayo Clinic
    • Overall Contact(s)
      • Sher-Lu Pai, MD, 904-953-2000, pai.sherlu@mayo.edu

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