Trial Outcomes & Findings for Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients (NCT NCT04054999)
NCT ID: NCT04054999
Last Updated: 2024-06-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
19 participants
Primary outcome timeframe
15, 30, 60, 90 and 120 minutes after initiation of treatment
Results posted on
2024-06-24
Participant Flow
Participant milestones
| Measure |
Cyanokit
Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
Hydroxocobalamin: Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
|
Methylene Blue
Single 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
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients
Baseline characteristics by cohort
| Measure |
Cyanokit
n=9 Participants
Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
Hydroxocobalamin: Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
|
Methylene Blue
n=10 Participants
Single 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
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
59 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15, 30, 60, 90 and 120 minutes after initiation of treatmentPopulation: Data was not collected nor analyzed at all for one participant in the Methylene Blue arm. The number of participants analyzed at each time point differs due to some participants completing their surgery earlier than others. Those participants were out of the surgical room by those time points and data was not collected nor analyzed.
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.
Outcome measures
| Measure |
Cyanokit
n=9 Participants
Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
Hydroxocobalamin: Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
|
Methylene Blue
n=9 Participants
Single 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
|
|---|---|---|
|
Systemic Vascular Resistance (SVR)
15 minutes
|
480 dyne*sec/cm^5
Interval 350.0 to 850.0
|
410 dyne*sec/cm^5
Interval 380.0 to 570.0
|
|
Systemic Vascular Resistance (SVR)
30 minutes
|
588 dyne*sec/cm^5
Interval 330.0 to 770.0
|
420 dyne*sec/cm^5
Interval 310.0 to 760.0
|
|
Systemic Vascular Resistance (SVR)
60 minutes
|
650 dyne*sec/cm^5
Interval 390.0 to 1170.0
|
480 dyne*sec/cm^5
Interval 300.0 to 940.0
|
|
Systemic Vascular Resistance (SVR)
90 minutes
|
571 dyne*sec/cm^5
Interval 430.0 to 990.0
|
530 dyne*sec/cm^5
Interval 330.0 to 610.0
|
|
Systemic Vascular Resistance (SVR)
120 minutes
|
543 dyne*sec/cm^5
Interval 440.0 to 1060.0
|
415 dyne*sec/cm^5
Interval 340.0 to 670.0
|
PRIMARY outcome
Timeframe: 15, 30, 60, 90 and 120 minutes after initiation of treatmentPopulation: The number of participants analyzed at each time point differs due to some participants completing their surgery earlier than others. Those participants were out of the surgical room by those time points and data was not collected nor analyzed.
Systolic blood pressure (top number of blood pressure reading). Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment.
Outcome measures
| Measure |
Cyanokit
n=9 Participants
Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
Hydroxocobalamin: Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
|
Methylene Blue
n=10 Participants
Single 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
|
|---|---|---|
|
Systolic Blood Pressure
15 minutes
|
109 Millimeters of Mercury
Interval 96.0 to 130.0
|
110 Millimeters of Mercury
Interval 63.0 to 120.0
|
|
Systolic Blood Pressure
30 minutes
|
113 Millimeters of Mercury
Interval 97.0 to 147.0
|
101 Millimeters of Mercury
Interval 87.0 to 130.0
|
|
Systolic Blood Pressure
60 minutes
|
120 Millimeters of Mercury
Interval 95.0 to 158.0
|
111 Millimeters of Mercury
Interval 92.0 to 145.0
|
|
Systolic Blood Pressure
90 minutes
|
129 Millimeters of Mercury
Interval 104.0 to 152.0
|
111 Millimeters of Mercury
Interval 90.0 to 162.0
|
|
Systolic Blood Pressure
120 minutes
|
116 Millimeters of Mercury
Interval 83.0 to 149.0
|
109 Millimeters of Mercury
Interval 101.0 to 161.0
|
PRIMARY outcome
Timeframe: 15, 30, 60, 90 and 120 minutes after initiation of treatmentPopulation: The number of participants analyzed at each time point differs due to some participants completing their surgery earlier than others. Those participants were out of the surgical room by those time points and data was not collected nor analyzed.
Diastolic blood pressure (bottom number of blood pressure reading). Measured during surgery at 15, 30, 60, 90 and 120 minutes after initiation of treatment.
Outcome measures
| Measure |
Cyanokit
n=9 Participants
Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
Hydroxocobalamin: Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
|
Methylene Blue
n=10 Participants
Single 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
|
|---|---|---|
|
Diastolic Blood Pressure
15 minutes
|
58 Millimeters of Mercury
Interval 40.0 to 66.0
|
55 Millimeters of Mercury
Interval 39.0 to 62.0
|
|
Diastolic Blood Pressure
30 minutes
|
57 Millimeters of Mercury
Interval 43.0 to 72.0
|
55 Millimeters of Mercury
Interval 41.0 to 68.0
|
|
Diastolic Blood Pressure
60 minutes
|
61 Millimeters of Mercury
Interval 39.0 to 73.0
|
55 Millimeters of Mercury
Interval 47.0 to 78.0
|
|
Diastolic Blood Pressure
90 minutes
|
60 Millimeters of Mercury
Interval 42.0 to 72.0
|
57 Millimeters of Mercury
Interval 50.0 to 70.0
|
|
Diastolic Blood Pressure
120 minutes
|
59 Millimeters of Mercury
Interval 47.0 to 78.0
|
57 Millimeters of Mercury
Interval 49.0 to 98.0
|
PRIMARY outcome
Timeframe: 15, 30, 60, 90 and 120 minutes after initiation of treatmentVasopressin as measured by the total amount of vasopressors administered. Measured at 15, 30, 60, 90 and 120 minutes after initiation of treatment.
Outcome measures
| Measure |
Cyanokit
n=9 Participants
Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
Hydroxocobalamin: Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
|
Methylene Blue
n=10 Participants
Single 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
|
|---|---|---|
|
Vasopressin
90 minutes
|
0.00 milli-units/kg/min
Interval 0.0 to 0.13
|
0.00 milli-units/kg/min
Interval 0.0 to 0.37
|
|
Vasopressin
120 minutes
|
0.00 milli-units/kg/min
Interval 0.0 to 0.11
|
0.00 milli-units/kg/min
Interval 0.0 to 0.31
|
|
Vasopressin
15 minutes
|
0.04 milli-units/kg/min
Interval 0.0 to 0.17
|
0.04 milli-units/kg/min
Interval 0.0 to 3.71
|
|
Vasopressin
30 minutes
|
0.04 milli-units/kg/min
Interval 0.0 to 0.13
|
0.04 milli-units/kg/min
Interval 0.0 to 3.37
|
|
Vasopressin
60 minutes
|
0.00 milli-units/kg/min
Interval 0.0 to 0.13
|
0.02 milli-units/kg/min
Interval 0.0 to 0.37
|
SECONDARY outcome
Timeframe: Up to 30 days after surgeryTotal number of days subjects were admitted to the ICU
Outcome measures
| Measure |
Cyanokit
n=9 Participants
Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
Hydroxocobalamin: Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
|
Methylene Blue
n=10 Participants
Single 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
|
|---|---|---|
|
Post-operative Intensive Care Unit (ICU) Length of Stay
|
1 days
Interval 0.0 to 20.0
|
0 days
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: Up to 30 days after surgeryTotal number of days subjects were admitted to the hospital
Outcome measures
| Measure |
Cyanokit
n=9 Participants
Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
Hydroxocobalamin: Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
|
Methylene Blue
n=10 Participants
Single 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
|
|---|---|---|
|
Hospital Length of Stay
|
7 days
Interval 5.0 to 56.0
|
7 days
Interval 0.0 to 12.0
|
SECONDARY outcome
Timeframe: Up to 30 days after surgeryThe number of subjects to experience a death, cardiopulmonary event, Acute Kidney injury (AKI), Myocardial infarctions (MI), Stroke or Surgical and medical procedures - Other.
Outcome measures
| Measure |
Cyanokit
n=9 Participants
Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
Hydroxocobalamin: Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
|
Methylene Blue
n=10 Participants
Single 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
|
|---|---|---|
|
Post-operative Complications
Death
|
1 participants
|
1 participants
|
|
Post-operative Complications
Cardiopulmonary Event
|
0 participants
|
1 participants
|
|
Post-operative Complications
AKI
|
0 participants
|
0 participants
|
|
Post-operative Complications
MI
|
0 participants
|
0 participants
|
|
Post-operative Complications
Stroke
|
0 participants
|
0 participants
|
|
Post-operative Complications
Surgical and medical procedures - Other.
|
1 participants
|
1 participants
|
Adverse Events
Cyanokit
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Methylene Blue
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cyanokit
n=9 participants at risk
Single dose intraoperatively of Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
Hydroxocobalamin: Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
|
Methylene Blue
n=10 participants at risk
Single 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
|
|---|---|---|
|
Cardiac disorders
Cardiopulmonary event
|
0.00%
0/9 • Adverse Events were collected from baseline until hospital discharge, approximately two months.
|
10.0%
1/10 • Adverse Events were collected from baseline until hospital discharge, approximately two months.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other.
|
11.1%
1/9 • Adverse Events were collected from baseline until hospital discharge, approximately two months.
|
10.0%
1/10 • Adverse Events were collected from baseline until hospital discharge, approximately two months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place