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

Phase 4

Completed

• Conditions: Vasoplegic Syndrome; Liver Transplant; Complications
• Interventions: Drug: Hydroxocobalamin; Drug: Methylene Blue

• Registration Number: NCT04054999
• Lead Sponsor: 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

Not available

Study Timeline

• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-13
• Study Start: 2019-11-30
• Primary Completion: 2023-02-27
• Study Completion: 2024-02-27
• Results First Submitted: 2024-05-28
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-19
• Last Update Submitted: 2024-06-19
• Results First Posted: 2024-06-24
• Last Update Posted: 2024-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyanokit	Hydroxocobalamin	Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
Methylene Blue	Methylene Blue	Single dose intraoperatively of Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes

Primary Outcome Measures

Name	Time	Method
Systemic Vascular Resistance (SVR)	15, 30, 60, 90 and 120 minutes after initiation of treatment	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.
Diastolic Blood Pressure	15, 30, 60, 90 and 120 minutes after initiation of treatment	Diastolic blood pressure (bottom number of blood pressure reading). Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment.
Vasopressin	15, 30, 60, 90 and 120 minutes after initiation of treatment	Vasopressin as measured by the total amount of vasopressors administered. Measured at 15, 30, 60, 90 and 120 minutes after initiation of treatment.
Systolic Blood Pressure	15, 30, 60, 90 and 120 minutes after initiation of treatment	Systolic blood pressure (top number of blood pressure reading). Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment.

Secondary Outcome Measures

Name	Time	Method
Post-operative Intensive Care Unit (ICU) Length of Stay	Up to 30 days after surgery	Total number of days subjects were admitted to the ICU
Post-operative Complications	Up to 30 days after surgery	The number of subjects to experience a death, cardiopulmonary event, Acute Kidney injury (AKI), Myocardial infarctions (MI), Stroke or Surgical and medical procedures - Other.
Hospital Length of Stay	Up to 30 days after surgery	Total number of days subjects were admitted to the hospital

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States