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

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ClinicalTrials.gov Identifier: NCT04054999
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Sher-Lu Pai, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Vasoplegic Syndrome Liver Transplant; Complications Drug: Hydroxocobalamin Drug: Methylene Blue Phase 4

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. .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, Open-Label, pilot study to describe the efficacy of hydroxocobalamin vs methylene blue
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Intravenous Hydroxocobalamin Versus Methylene Blue as Treatment for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients
Estimated Study Start Date : November 30, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Systemic Vascular Resistance (SVR) [ Time Frame: Intraoperative period ]
    Improving hemodynamic stability as measured by SVR

  2. Blood pressure (BP) [ Time Frame: Intraoperative period ]
    Improving hemodynamic stability as measured by systemic blood pressure

  3. Vasopressors [ Time Frame: Intraoperative period ]
    Improving hemodynamic stability as measured by amount of vasopressors administered.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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).

  4. Graft function [ Time Frame: Up to 1 year after surgery ]
    Patient outcomes in the postoperative period as measured by graft function

  5. Survival rate [ Time Frame: Up to 1 year after surgery ]
    Patient outcomes in the postoperative period as measured by survival rate



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054999


Contacts
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Contact: Sher-Lu Pai, MD 904-953-2000 pai.sherlu@mayo.edu

Locations
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United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Sher-Lu Pai, MD Mayo Clinic

Additional Information:
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Responsible Party: Sher-Lu Pai, Consultant in Anesthesia, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04054999     History of Changes
Other Study ID Numbers: 18-006247
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sher-Lu Pai, Mayo Clinic:
hydroxocobalamin
methylene blue
Additional relevant MeSH terms:
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Vasoplegia
Syndrome
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Hydroxocobalamin
Vitamin B 12
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs