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

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Liver Transplant; Complications; Vasoplegic Syndrome

Treatments: Drug: Methylene Blue; Drug: Hydroxocobalamin

Study type: Interventional

Funder types: Other

Identifiers

NCT04054999

18-006247

Details and patient eligibility

About

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

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Cyanokit

Experimental group

Description:

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

Treatment:

Drug: Hydroxocobalamin

Methylene Blue

Active Comparator group

Description:

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

Treatment:

Drug: Methylene Blue