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

Study Overview
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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.

Detailed Description
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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. .

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

Conditions
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Vasoplegic Syndrome, Liver Transplant; Complications

Intervention / Treatment
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* Drug: Hydroxocobalamin
* Drug: Methylene Blue


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Open-Label, pilot study to describe the efficacy of hydroxocobalamin vs methylene blue
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyanokit<br>Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes | Drug: Hydroxocobalamin<br>* Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes<br>|
| Active Comparator: Methylene Blue<br>Single dose intraoperatively of Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes | Drug: Methylene Blue<br>* Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic Vascular Resistance (SVR) | Improving hemodynamic stability as measured by SVR | Intraoperative period | 
| Blood pressure (BP) | Improving hemodynamic stability as measured by systemic blood pressure | Intraoperative period | 
| Vasopressors | Improving hemodynamic stability as measured by amount of vasopressors administered. | Intraoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early tracheal extubation | Patient outcomes in the postoperative period as measured by early tracheal extubation after surgery | up to 1 day after surgery | 
| 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 | 
| 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 | 
| Graft function | Patient outcomes in the postoperative period as measured by graft function | Up to 1 year after surgery | 
| Survival rate | Patient outcomes in the postoperative period as measured by survival rate | Up to 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hydroxocobalamin, methylene blue