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

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT04054999

Collaborator

(none)

Enrollment

Location

Arms

49.1

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

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. .

Study Design

Study Type:

Interventional

Anticipated 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 blueRandomized, 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

Actual Study Start Date :

Nov 30, 2019

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Early tracheal extubation [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 [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 [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 [Up to 1 year after surgery]
Patient outcomes in the postoperative period as measured by graft function
Survival rate [Up to 1 year after surgery]
Patient outcomes in the postoperative period as measured by survival rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)