Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients
Primary Purpose
Vasoplegic Syndrome, Liver Transplant; Complications
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hydroxocobalamin
Methylene Blue
Sponsored by
About this trial
This is an interventional treatment trial for Vasoplegic Syndrome focused on measuring hydroxocobalamin, methylene blue
Eligibility 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)
Sites / Locations
- Mayo Clinic in FloridaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cyanokit
Methylene Blue
Arm Description
Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
Single dose intraoperatively of Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes
Outcomes
Primary Outcome Measures
Systemic Vascular Resistance (SVR)
Improving hemodynamic stability as measured by SVR
Blood pressure (BP)
Improving hemodynamic stability as measured by systemic blood pressure
Vasopressors
Improving hemodynamic stability as measured by amount of vasopressors administered.
Secondary Outcome Measures
Early tracheal extubation
Patient outcomes in the postoperative period as measured by early tracheal extubation after surgery
Length of hospital and intensive care unit stay
Patient outcomes in the postoperative period as measured by length of hospital and intensive care unit stay
Perioperative complications
Patient outcomes in the postoperative period as measured by perioperative complications (stroke, myocardial infarction, and acute renal failure).
Graft function
Patient outcomes in the postoperative period as measured by graft function
Survival rate
Patient outcomes in the postoperative period as measured by survival rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04054999
Brief Title
Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients
Official Title
The Efficacy of Intravenous Hydroxocobalamin Versus Methylene Blue as Treatment for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2019 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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. .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasoplegic Syndrome, Liver Transplant; Complications
Keywords
hydroxocobalamin, methylene blue
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Open-Label, pilot study to describe the efficacy of hydroxocobalamin vs methylene blue
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cyanokit
Arm Type
Experimental
Arm Description
Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
Arm Title
Methylene Blue
Arm Type
Active Comparator
Arm Description
Single dose intraoperatively of Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes
Intervention Type
Drug
Intervention Name(s)
Hydroxocobalamin
Intervention Description
Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
Intervention Type
Drug
Intervention Name(s)
Methylene Blue
Intervention Description
Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes
Primary Outcome Measure Information:
Title
Systemic Vascular Resistance (SVR)
Description
Improving hemodynamic stability as measured by SVR
Time Frame
Intraoperative period
Title
Blood pressure (BP)
Description
Improving hemodynamic stability as measured by systemic blood pressure
Time Frame
Intraoperative period
Title
Vasopressors
Description
Improving hemodynamic stability as measured by amount of vasopressors administered.
Time Frame
Intraoperative period
Secondary Outcome Measure Information:
Title
Early tracheal extubation
Description
Patient outcomes in the postoperative period as measured by early tracheal extubation after surgery
Time Frame
up to 1 day after surgery
Title
Length of hospital and intensive care unit stay
Description
Patient outcomes in the postoperative period as measured by length of hospital and intensive care unit stay
Time Frame
Up to 30 days after surgery
Title
Perioperative complications
Description
Patient outcomes in the postoperative period as measured by perioperative complications (stroke, myocardial infarction, and acute renal failure).
Time Frame
Up to 30 days after surgery
Title
Graft function
Description
Patient outcomes in the postoperative period as measured by graft function
Time Frame
Up to 1 year after surgery
Title
Survival rate
Description
Patient outcomes in the postoperative period as measured by survival rate
Time Frame
Up to 1 year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sher-Lu Pai, MD
Phone
904-953-2000
Email
pai.sherlu@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sher-Lu Pai, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan in place.
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients
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