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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 14, 2019
Sponsor:
Information provided by (Responsible Party):
Sher-Lu Pai, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE August 12, 2019
First Posted Date  ICMJE August 13, 2019
Last Update Posted Date October 14, 2019
Estimated Study Start Date  ICMJE November 30, 2019
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04054999 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE [Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients]
Official Title  ICMJE The Efficacy of Intravenous Hydroxocobalamin Versus Methylene Blue as Treatment for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients
Brief Summary This study will evaluate if Hydroxocobalamin may be a new and possibly superior treatment for refractory vasoplegic syndrome during liver transplant surgery.
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. .
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Vasoplegic Syndrome
  • Liver Transplant; Complications
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Cyanokit
    Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
    Intervention: Drug: Hydroxocobalamin
  • Active Comparator: Methylene Blue
    Single dose intraoperatively of Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes
    Intervention: Drug: Methylene Blue
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 12, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2021
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sher-Lu Pai, MD 904-953-2000 pai.sherlu@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04054999
Other Study ID Numbers  ICMJE 18-006247
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan in place.
Responsible Party Sher-Lu Pai, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sher-Lu Pai, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP