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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2024-02-27

Brief Summary

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

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Detailed Description

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Conditions

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Vasoplegic Syndrome Liver Transplant; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, Open-Label, pilot study to describe the efficacy of hydroxocobalamin vs methylene blue

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cyanokit

Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes

Group Type EXPERIMENTAL

Hydroxocobalamin

Intervention Type DRUG

Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes

Methylene Blue

Single dose intraoperatively of Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes

Group Type ACTIVE_COMPARATOR

Methylene Blue

Intervention Type DRUG

Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes

Interventions

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Hydroxocobalamin

Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes

Intervention Type DRUG

Methylene Blue

Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No