NCT04054999

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

Completed Phase 4 Results posted Last updated 24 June 2024

What this trial tests

Phase 4 trial testing Hydroxocobalamin in Vasoplegic Syndrome in 19 participants. Completed in 27 February 2024.

Timeline

30 November 2019

Primary endpoint
27 February 2023

27 February 2024

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	30 November 2019
Primary completion	27 February 2023
Estimated completion	27 February 2024
Sites	1 location across United States

Drugs / interventions tested

• Hydroxocobalamin (HYDROXOCOBALAMIN) — full drug profile →
• Methylene Blue (METHYLENE BLUE) — full drug profile →

Conditions studied

• Vasoplegic Syndrome — all drugs for Vasoplegic Syndrome →
• Liver Transplant; Complications — all drugs for Liver Transplant; Complications →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Vasoplegic Syndrome or Liver Transplant; Complications. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Systemic Vascular Resistance (SVR) Primary · 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.

15 minutes

Group	Value	95% CI
Cyanokit	480	350 – 850
Methylene Blue	410	380 – 570

30 minutes

Group	Value	95% CI
Cyanokit	588	330 – 770
Methylene Blue	420	310 – 760

60 minutes

Group	Value	95% CI
Cyanokit	650	390 – 1170
Methylene Blue	480	300 – 940

90 minutes

Group	Value	95% CI
Cyanokit	571	430 – 990
Methylene Blue	530	330 – 610

120 minutes

Group	Value	95% CI
Cyanokit	543	440 – 1060
Methylene Blue	415	340 – 670

Systolic Blood Pressure Primary · 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.

15 minutes

Group	Value	95% CI
Cyanokit	109	96 – 130
Methylene Blue	110	63 – 120

30 minutes

Group	Value	95% CI
Cyanokit	113	97 – 147
Methylene Blue	101	87 – 130

60 minutes

Group	Value	95% CI
Cyanokit	120	95 – 158
Methylene Blue	111	92 – 145

90 minutes

Group	Value	95% CI
Cyanokit	129	104 – 152
Methylene Blue	111	90 – 162

120 minutes

Group	Value	95% CI
Cyanokit	116	83 – 149
Methylene Blue	109	101 – 161

Diastolic Blood Pressure Primary · 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.

15 minutes

Group	Value	95% CI
Cyanokit	58	40 – 66
Methylene Blue	55	39 – 62

30 minutes

Group	Value	95% CI
Cyanokit	57	43 – 72
Methylene Blue	55	41 – 68

60 minutes

Group	Value	95% CI
Cyanokit	61	39 – 73
Methylene Blue	55	47 – 78

90 minutes

Group	Value	95% CI
Cyanokit	60	42 – 72
Methylene Blue	57	50 – 70

120 minutes

Group	Value	95% CI
Cyanokit	59	47 – 78
Methylene Blue	57	49 – 98

Vasopressin Primary · 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.

15 minutes

Group	Value	95% CI
Cyanokit	0.04	0.00 – 0.17
Methylene Blue	0.04	0.00 – 3.71

30 minutes

Group	Value	95% CI
Cyanokit	0.04	0.00 – 0.13
Methylene Blue	0.04	0.00 – 3.37

60 minutes

Group	Value	95% CI
Cyanokit	0.00	0.00 – 0.13
Methylene Blue	0.02	0.00 – 0.37

90 minutes

Group	Value	95% CI
Cyanokit	0.00	0.00 – 0.13
Methylene Blue	0.00	0.00 – 0.37

120 minutes

Group	Value	95% CI
Cyanokit	0.00	0.00 – 0.11
Methylene Blue	0.00	0.00 – 0.31

Post-operative Intensive Care Unit (ICU) Length of Stay Secondary · Up to 30 days after surgery

Total number of days subjects were admitted to the ICU

Group	Value	95% CI
Cyanokit	1	0 – 20
Methylene Blue	0	0 – 4

Hospital Length of Stay Secondary · Up to 30 days after surgery

Total number of days subjects were admitted to the hospital

Group	Value	95% CI
Cyanokit	7	5 – 56
Methylene Blue	7	0 – 12

Post-operative Complications Secondary · 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.

Death

Group	Value	95% CI
Cyanokit	1
Methylene Blue	1

Cardiopulmonary Event

Group	Value	95% CI
Cyanokit	0
Methylene Blue	1

AKI

Group	Value	95% CI
Cyanokit	0
Methylene Blue	0

MI

Group	Value	95% CI
Cyanokit	0
Methylene Blue	0

Stroke

Group	Value	95% CI
Cyanokit	0
Methylene Blue	0

Surgical and medical procedures - Other.

Group	Value	95% CI
Cyanokit	1
Methylene Blue	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events were collected from baseline until hospital discharge, approximately two months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cyanokit

Serious: 0/9 (0%)

Deaths: 1/9

Methylene Blue

Serious: 0/10 (0%)

Deaths: 1/10

Other adverse events (2 terms — click to expand)

Reaction	System	Cyanokit	Methylene Blue
Cardiopulmonary event	Cardiac disorders	—	—
Surgical and medical procedures - Other.	Surgical and medical procedures	—	—

Data from ClinicalTrials.gov NCT04054999 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.