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

NCT04054999 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 18-006247
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vasoplegic Syndrome; Liver Transplant; Complications

Keywords

hydroxocobalamin; methylene blue

Outcome Measures

Primary Outcomes (4)

• Systemic Vascular Resistance (SVR)

  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.

  15, 30, 60, 90 and 120 minutes after initiation of treatment

• Systolic Blood Pressure

  Systolic blood pressure (top number of blood pressure reading). Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment.

  15, 30, 60, 90 and 120 minutes after initiation of treatment

• Diastolic Blood Pressure

  Diastolic blood pressure (bottom number of blood pressure reading). Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment.

  15, 30, 60, 90 and 120 minutes after initiation of treatment

• Vasopressin

  Vasopressin as measured by the total amount of vasopressors administered. Measured at 15, 30, 60, 90 and 120 minutes after initiation of treatment.

  15, 30, 60, 90 and 120 minutes after initiation of treatment

Secondary Outcomes (3)

• Post-operative Intensive Care Unit (ICU) Length of Stay

  Up to 30 days after surgery

• Hospital Length of Stay

  Up to 30 days after surgery

• Post-operative Complications

  Up to 30 days after surgery

Study Arms (2)

Cyanokit

EXPERIMENTAL

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

Drug: Hydroxocobalamin

Methylene Blue

ACTIVE COMPARATOR

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

Drug: Methylene Blue

Interventions

Hydroxocobalamin DRUG

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

Cyanokit

Methylene Blue DRUG

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

Methylene Blue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Vasoplegia

Interventions

Hydroxocobalamin; Methylene Blue

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vitamin B 12; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Sher-Lu Pai, M.D.
• Organization: Mayo Clinic

Pai.SherLu@mayo.edu

904-956-3327

Study Officials

• Sher-Lu Pai, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Anesthesia

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

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 13, 2019
• Study Start: November 30, 2019
• Primary Completion: February 27, 2023
• Study Completion: February 27, 2024
• Last Updated: June 24, 2024
• Results First Posted: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)