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Vitamin B12 Analog

Methylene Blue vs Cyanokit for Vasoplegic Syndrome

Phase 4

Recruiting

Led By Sher-Lu Pai, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraoperative period

Awards & highlights

Study Summary

This trial will test if a new treatment for a life-threatening condition during liver transplant surgery is better than the current standard of care.

Who is the study for?

This trial is for liver transplant patients who can understand the consent form or have someone legally authorized to consent on their behalf. They must show a specific low resistance in their blood vessels during surgery to qualify.Check my eligibility

What is being tested?

The study compares Methylene Blue and Hydroxocobalamin treatments for vasoplegic syndrome, which occurs during liver transplants. It aims to find out if Hydroxocobalamin is better at managing this complication.See study design

What are the potential side effects?

Possible side effects of Methylene Blue include urine discoloration, dizziness, chest pain, headache, or high blood pressure. Hydroxocobalamin may cause red discoloration of the skin and urine, nausea, headache, or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 day after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 day after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 day after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Blood pressure (BP)

Systemic Vascular Resistance (SVR)

Vasopressors

Secondary outcome measures

Early tracheal extubation

Graft function

Length of hospital and intensive care unit stay

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CyanokitExperimental Treatment1 Intervention

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

Group II: Methylene BlueActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hydroxocobalamin

2014

Completed Phase 4

~50

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,205 Previous Clinical Trials

3,766,764 Total Patients Enrolled

1 Trials studying Vasoplegic Syndrome

8 Patients Enrolled for Vasoplegic Syndrome

Sher-Lu Pai, MDPrincipal Investigator - Mayo Clinic

Mayo Clinic Hospital Jacksonville

Media Library

Hydroxocobalamin (Vitamin B12 Analog) Clinical Trial Eligibility Overview. Trial Name: NCT04054999 — Phase 4

Vasoplegic Syndrome Research Study Groups: Cyanokit, Methylene Blue

Vasoplegic Syndrome Clinical Trial 2023: Hydroxocobalamin Highlights & Side Effects. Trial Name: NCT04054999 — Phase 4

Hydroxocobalamin (Vitamin B12 Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04054999 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently eligible for this experiment?

"Affirmative. Details on clinicaltrials.gov highlight that this research project is currently enrolling participants, with the initial post dated November 30th 2019 and the most recent edit made December 28th 2021. Twenty patients require recruitment across a single medical centre."

Answered by AI

What ultimate outcome is this clinical trial aiming to realize?

"The primary goal of this trial, evaluated over the duration of surgery, is to measure blood pressure (BP). Also taken into account are postoperative complications like strokes, myocardial infarctions and acute renal failure; graft function; and survival rate."

Answered by AI

Where is Hydroxocobalamin typically prescribed?

"Hydroxocobalamin is typically employed as a treatment for cystitis, but it may also be prescribed to help patients manage behavior disorders, fractures and multiple body tissue issues."

Answered by AI

Has Hydroxocobalamin been granted clearance from the FDA?

"Taking into consideration that Hydroxocobalamin is a Phase 4 medication, our team at Power gave it the highest safety rating of 3."

Answered by AI

Are there presently any opportunities to join this research project?

"As per the information found on clinicaltrials.gov, this research is currently seeking eligible participants. The experiment was first listed on November 30th 2019 and updated most recently on December 28th 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Sher-Lu Pai 2019. "Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04054999.

All > Liver Transplant