Trial Outcomes & Findings for Vitamin B12a Vasoplegic Syndrome (NCT NCT03735316)
NCT ID: NCT03735316
Last Updated: 2023-05-10
Results Overview
The average pressure in a patient's arteries during one cardiac cycle
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
baseline, 4 hours
Results posted on
2023-05-10
Participant Flow
Participant milestones
| Measure |
B12a
Subjects received Hydroxocobalamin marketed as Cyanokit®, 5g, IV
Hydroxocobalamin: 5g, IV, Infused once over 15 minutes. The drug comes in a 250ml glass vial with 5g of lyophilized hydroxocobalamin to be reconstituted in 200ml of Normal Saline, Dextrose or Lactated Ringers.
Cardiopulmonary Bypass: Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
|
Placebo
Subjects received placebo
Cardiopulmonary Bypass: Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
Placebos: Placebo is a Normal Saline, 5g, IV, Infused once over 15 minutes. The placebo comes in a 250ml glass vial.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin B12a Vasoplegic Syndrome
Baseline characteristics by cohort
| Measure |
B12a
n=4 Participants
Subjects received Hydroxocobalamin marketed as Cyanokit®, 5g, IV
Hydroxocobalamin: 5g, IV, Infused once over 15 minutes. The drug comes in a 250ml glass vial with 5g of lyophilized hydroxocobalamin to be reconstituted in 200ml of Normal Saline, Dextrose or Lactated Ringers.
Cardiopulmonary Bypass: Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
|
Placebo
n=4 Participants
Subjects received placebo
Cardiopulmonary Bypass: Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
Placebos: Placebo is a Normal Saline, 5g, IV, Infused once over 15 minutes. The placebo comes in a 250ml glass vial.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=99 Participants
|
70 years
n=107 Participants
|
69 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
8 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline, 4 hoursPopulation: Terminated study. Insufficient recruitment over study period
The average pressure in a patient's arteries during one cardiac cycle
Outcome measures
| Measure |
B12a
n=4 Participants
Subjects received Hydroxocobalamin marketed as Cyanokit®, 5g, IV
Hydroxocobalamin: 5g, IV, Infused once over 15 minutes. The drug comes in a 250ml glass vial with 5g of lyophilized hydroxocobalamin to be reconstituted in 200ml of Normal Saline, Dextrose or Lactated Ringers.
Cardiopulmonary Bypass: Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
|
Placebo
n=4 Participants
Subjects received placebo
Cardiopulmonary Bypass: Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
Placebos: Placebo is a Normal Saline, 5g, IV, Infused once over 15 minutes. The placebo comes in a 250ml glass vial.
|
|---|---|---|
|
Change in Mean Arterial Pressure
|
6 mmHg
Interval 1.25 to 9.5
|
-0.5 mmHg
Interval -2.75 to 1.25
|
SECONDARY outcome
Timeframe: baseline, 4 hoursPopulation: Terminated study. Insufficient recruitment over study period
Vasopressors are administered and adjusted to maintain blood pressure. The combined dose of vasopressor dosage was calculated as norepinepheine equivalents listed in Table 1 of the protocol appendix and measured as a secondary outcome through the first 4 hours after intevention.
Outcome measures
| Measure |
B12a
n=4 Participants
Subjects received Hydroxocobalamin marketed as Cyanokit®, 5g, IV
Hydroxocobalamin: 5g, IV, Infused once over 15 minutes. The drug comes in a 250ml glass vial with 5g of lyophilized hydroxocobalamin to be reconstituted in 200ml of Normal Saline, Dextrose or Lactated Ringers.
Cardiopulmonary Bypass: Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
|
Placebo
n=4 Participants
Subjects received placebo
Cardiopulmonary Bypass: Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
Placebos: Placebo is a Normal Saline, 5g, IV, Infused once over 15 minutes. The placebo comes in a 250ml glass vial.
|
|---|---|---|
|
Change in Norepinephrine Equivalent Infusion Rate. Norepinephrine Equivalent Table is Listed in the Study Protocol
|
-0.035 mcg/kg/min
Interval -0.0625 to -0.015
|
0.02 mcg/kg/min
Interval 0.0075 to 0.0425
|
SECONDARY outcome
Timeframe: baseline, 4 hoursPopulation: Terminated study. Insufficient recruitment over study period
The maximum arterial pressure during contraction of the left ventricle of the heart.
Outcome measures
| Measure |
B12a
n=4 Participants
Subjects received Hydroxocobalamin marketed as Cyanokit®, 5g, IV
Hydroxocobalamin: 5g, IV, Infused once over 15 minutes. The drug comes in a 250ml glass vial with 5g of lyophilized hydroxocobalamin to be reconstituted in 200ml of Normal Saline, Dextrose or Lactated Ringers.
Cardiopulmonary Bypass: Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
|
Placebo
n=4 Participants
Subjects received placebo
Cardiopulmonary Bypass: Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
Placebos: Placebo is a Normal Saline, 5g, IV, Infused once over 15 minutes. The placebo comes in a 250ml glass vial.
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
5.5 mmHg
Interval -0.5 to 9.75
|
0.5 mmHg
Interval -1.25 to 1.25
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Terminated study. Insufficient recruitment over study period
Number subject deaths
Outcome measures
| Measure |
B12a
n=4 Participants
Subjects received Hydroxocobalamin marketed as Cyanokit®, 5g, IV
Hydroxocobalamin: 5g, IV, Infused once over 15 minutes. The drug comes in a 250ml glass vial with 5g of lyophilized hydroxocobalamin to be reconstituted in 200ml of Normal Saline, Dextrose or Lactated Ringers.
Cardiopulmonary Bypass: Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
|
Placebo
n=4 Participants
Subjects received placebo
Cardiopulmonary Bypass: Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
Placebos: Placebo is a Normal Saline, 5g, IV, Infused once over 15 minutes. The placebo comes in a 250ml glass vial.
|
|---|---|---|
|
Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Terminated study. Insufficient recruitment over study period
Number of days subjects are hospitalized
Outcome measures
| Measure |
B12a
n=4 Participants
Subjects received Hydroxocobalamin marketed as Cyanokit®, 5g, IV
Hydroxocobalamin: 5g, IV, Infused once over 15 minutes. The drug comes in a 250ml glass vial with 5g of lyophilized hydroxocobalamin to be reconstituted in 200ml of Normal Saline, Dextrose or Lactated Ringers.
Cardiopulmonary Bypass: Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
|
Placebo
n=4 Participants
Subjects received placebo
Cardiopulmonary Bypass: Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
Placebos: Placebo is a Normal Saline, 5g, IV, Infused once over 15 minutes. The placebo comes in a 250ml glass vial.
|
|---|---|---|
|
Duration of Hospital Stay
|
11.5 days
Interval 8.0 to 16.5
|
15 days
Interval 12.5 to 18.0
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Terminated study. Insufficient recruitment over study period
Number of days subjects are in the intensive care unit
Outcome measures
| Measure |
B12a
n=4 Participants
Subjects received Hydroxocobalamin marketed as Cyanokit®, 5g, IV
Hydroxocobalamin: 5g, IV, Infused once over 15 minutes. The drug comes in a 250ml glass vial with 5g of lyophilized hydroxocobalamin to be reconstituted in 200ml of Normal Saline, Dextrose or Lactated Ringers.
Cardiopulmonary Bypass: Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
|
Placebo
n=4 Participants
Subjects received placebo
Cardiopulmonary Bypass: Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
Placebos: Placebo is a Normal Saline, 5g, IV, Infused once over 15 minutes. The placebo comes in a 250ml glass vial.
|
|---|---|---|
|
Duration of Intensive Care Stay
|
6 days
Interval 3.75 to 9.5
|
8.50 days
Interval 6.5 to 9.25
|
Adverse Events
B12a
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
B12a
n=4 participants at risk
Subjects received Hydroxocobalamin marketed as Cyanokit®, 5g, IV
Hydroxocobalamin: 5g, IV, Infused once over 15 minutes. The drug comes in a 250ml glass vial with 5g of lyophilized hydroxocobalamin to be reconstituted in 200ml of Normal Saline, Dextrose or Lactated Ringers.
Cardiopulmonary Bypass: Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
|
Placebo
n=4 participants at risk
Subjects received placebo
Cardiopulmonary Bypass: Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
Placebos: Placebo is a Normal Saline, 5g, IV, Infused once over 15 minutes. The placebo comes in a 250ml glass vial.
|
|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/4 • Adverse Events were collected from baseline to end of study, approximately 30 days
|
50.0%
2/4 • Adverse Events were collected from baseline to end of study, approximately 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place