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

Liver Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04054999
• Other study ID #: 18-006247
• Status: Recruiting
• Phase: Phase 4
• Start date: November 30, 2019
• Est. completion date: January 2024

Study information

• Verified date: December 2022
• Source: Mayo Clinic
• Contact: Sher-Lu Pai, MD
• Phone: 904-953-2000
• Email: pai.sherlu[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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. .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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)

Related Conditions & MeSH terms

• Liver Transplant; Complications
• Syndrome
• Vasoplegia
• Vasoplegic Syndrome

Intervention

Drug:
• Hydroxocobalamin
Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
• Methylene Blue
Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systemic Vascular Resistance (SVR)	Improving hemodynamic stability as measured by SVR	Intraoperative period
Primary	Blood pressure (BP)	Improving hemodynamic stability as measured by systemic blood pressure	Intraoperative period
Primary	Vasopressors	Improving hemodynamic stability as measured by amount of vasopressors administered.	Intraoperative period
Secondary	Early tracheal extubation	Patient outcomes in the postoperative period as measured by early tracheal extubation after surgery	up to 1 day after surgery
Secondary	Length of hospital and intensive care unit stay	Patient outcomes in the postoperative period as measured by length of hospital and intensive care unit stay	Up to 30 days after surgery
Secondary	Perioperative complications	Patient outcomes in the postoperative period as measured by perioperative complications (stroke, myocardial infarction, and acute renal failure).	Up to 30 days after surgery
Secondary	Graft function	Patient outcomes in the postoperative period as measured by graft function	Up to 1 year after surgery
Secondary	Survival rate	Patient outcomes in the postoperative period as measured by survival rate	Up to 1 year after surgery

External Links

•   Mayo Clinic Clinical Trials