Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT04054999Other id18-006247

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 19 participants (actual)
Sponsor: Mayo Clinic · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 30 Nov 2019
Primary completion: 27 Feb 2023
Completion: 27 Feb 2024
First posted: 13 Aug 2019
Last update posted: 24 Jun 2024
Conditions: Vasoplegic Syndrome · Liver Transplant; Complications

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2019202020212022202320242025

Ph 4
Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients
NCT04054999
30 Nov 2019 to 27 Feb 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

HydroxocobalaminDrug
Methylene BlueDrug

Arms2

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

Primary outcomes4

Outcomes the sponsor listed as primary.

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

Secondary outcomes(3)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

Systemic Vascular Resistance (SVR)

Group	Value (dyne*sec/cm^5)
Cyanokit	480
Methylene Blue	410

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

Systolic Blood Pressure

Group	Value (Millimeters of Mercury)
Cyanokit	109
Methylene Blue	110

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

Diastolic Blood Pressure

Group	Value (Millimeters of Mercury)
Cyanokit	58
Methylene Blue	55

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

Vasopressin

Group	Value (milli-units/kg/min)
Cyanokit	0.04
Methylene Blue	0.04

Secondary and other outcome results(3)

Secondary outcomeMedian· Up to 30 days after surgery

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

Group	Value (days)
Cyanokit	1
Methylene Blue	0

Secondary outcomeMedian· Up to 30 days after surgery

Hospital Length of Stay

Group	Value (days)
Cyanokit	7
Methylene Blue	7

Secondary outcomeNumber· Up to 30 days after surgery

Post-operative Complications

Group	Value (participants)
Cyanokit	1
Methylene Blue	1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
CyanokitSingle dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes Hydroxocobalamin: Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes	1 / 9	0 / 9	1 / 9
Methylene BlueSingle dose intraoperatively of Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes Methylene Blue: Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes	1 / 10	0 / 10	2 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

* 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)

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