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

Mayo Clinic19 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vasoplegic Syndrome Liver Transplant; Complications

Interventions

HydroxocobalaminDRUG

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

Methylene BlueDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* 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)

Locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Systemic Vascular Resistance (SVR)

SVR refers to the resistance to blood flow offered by all of the systemic vasculature, excluding the pulmonary vasculature. Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment.

Time frame: 15, 30, 60, 90 and 120 minutes after initiation of treatment

Systolic Blood Pressure

Systolic blood pressure (top number of blood pressure reading). Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment.

Time frame: 15, 30, 60, 90 and 120 minutes after initiation of treatment

Diastolic Blood Pressure

Diastolic blood pressure (bottom number of blood pressure reading). Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment.

Time frame: 15, 30, 60, 90 and 120 minutes after initiation of treatment

Vasopressin

Vasopressin as measured by the total amount of vasopressors administered. Measured at 15, 30, 60, 90 and 120 minutes after initiation of treatment.

Time frame: 15, 30, 60, 90 and 120 minutes after initiation of treatment

Secondary Outcomes

Post-operative Intensive Care Unit (ICU) Length of Stay

Total number of days subjects were admitted to the ICU

Time frame: Up to 30 days after surgery

Hospital Length of Stay

Total number of days subjects were admitted to the hospital

Time frame: Up to 30 days after surgery

Post-operative Complications

Data from ClinicalTrials.gov

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