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

The Efficacy of Intravenous Hydroxocobalamin Versus Methylene Blue as Treatment for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients

Sponsors

Lead Sponsor: Mayo Clinic

Source Mayo Clinic
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. .

Overall Status Recruiting
Start Date 2021-12-30
Completion Date 2022-01-01
Primary Completion Date 2022-01-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Systemic Vascular Resistance (SVR) Intraoperative period
Blood pressure (BP) Intraoperative period
Vasopressors Intraoperative period
Secondary Outcome
Measure Time Frame
Early tracheal extubation up to 1 day after surgery
Length of hospital and intensive care unit stay Up to 30 days after surgery
Perioperative complications Up to 30 days after surgery
Graft function Up to 1 year after surgery
Survival rate Up to 1 year after surgery
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: Hydroxocobalamin

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

Arm Group Label: Cyanokit

Intervention Type: Drug

Intervention Name: Methylene Blue

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

Arm Group Label: 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)

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Sher-Lu Pai, MD Principal Investigator Mayo Clinic
Overall Contact

Last Name: Sher-Lu Pai, MD

Phone: 904-953-2000

Email: [email protected]

Location
Facility: Status: Mayo Clinic in Florida
Location Countries

United States

Verification Date

2020-12-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Mayo Clinic

Investigator Full Name: Sher-Lu Pai

Investigator Title: Consultant in Anesthesia

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Cyanokit

Type: Experimental

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

Label: Methylene Blue

Type: Active Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

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

Primary Purpose: Treatment

Masking: None (Open Label)

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