A Phase 2 interventional study of Hydroxocobalamin and Cardiopulmonary Bypass in Vasoplegic Syndrome, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-10.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Supportive care
The study team will evaluate the medication Hydroxocobalamin (B12a) for treatment of low blood pressure after cardiac surgery.
If subjects meet the criteria for inclusion in the study based on the subjects blood pressure the subject will be randomized to receive the study drug or a placebo. Subjects blood pressure will be monitored closely for the first 30 minutes and then have standard intensive care unit (ICU) care afterwards. Kidney dysfunction will be assessed for changes in urine production and laboratory values that are followed as a part of standard postoperative care. Study coordinators will obtain these values from subjects medical records for 7 days and subjects will be contacted by phone for follow up after 30 days.
48 studies on the registry are indexed under Vasoplegia; 19 are open to participants now.
This study's enrollment of 8 is below the median of 110 across 27 interventional studies indexed under Vasoplegia.
Browse Vasoplegia studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive Hydroxocobalamin marketed as Cyanokit®, 5g, IV
Drug: Hydroxocobalamin · Procedure: Cardiopulmonary Bypass
Subjects will receive placebo
Procedure: Cardiopulmonary Bypass · Drug: Placebos
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.
Also known as: Cyanokit®, Vitamin B12a
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.
Also known as: CPB
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
The average pressure in a patient's arteries during one cardiac cycle
Time frame: baseline, 4 hours
Change in Norepinephrine Equivalent Infusion Rate. Norepinephrine Equivalent Table is Listed in the Study Protocol
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.
Time frame: baseline, 4 hours
Change in Systolic Blood Pressure
The maximum arterial pressure during contraction of the left ventricle of the heart.
Time frame: baseline, 4 hours
Death
Number subject deaths
Time frame: 30 days
Duration of Hospital Stay
Number of days subjects are hospitalized
Time frame: 30 days
Duration of Intensive Care Stay
Number of days subjects are in the intensive care unit
Time frame: 30 days
| Milestone | B12a | Placebo |
|---|---|---|
| Started | 4 | 4 |
| Completed | 4 | 4 |
| Not completed | 0 | 0 |
The average pressure in a patient's arteries during one cardiac cycle
| mmHg | B12a | Placebo |
|---|---|---|
| Change in Mean Arterial Pressure | 6 (1.25 to 9.5) | -0.5 (-2.75 to 1.25) |
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.
| mcg/kg/min | B12a | Placebo |
|---|---|---|
| Change in Norepinephrine Equivalent Infusion Rate. Norepinephrine Equivalent Table is Listed in the Study Protocol | -0.035 (-0.0625 to -0.0150) | 0.02 (0.0075 to 0.0425) |
The maximum arterial pressure during contraction of the left ventricle of the heart.
| mmHg | B12a | Placebo |
|---|---|---|
| Change in Systolic Blood Pressure | 5.5 (-0.5 to 9.75) | 0.5 (-1.25 to 1.25) |
Number subject deaths
| Participants | B12a | Placebo |
|---|---|---|
| Death | 0 | 0 |
Number of days subjects are hospitalized
| days | B12a | Placebo |
|---|---|---|
| Duration of Hospital Stay | 11.5 (8 to 16.5) | 15 (12.5 to 18.0) |
Number of days subjects are in the intensive care unit
| days | B12a | Placebo |
|---|---|---|
| Duration of Intensive Care Stay | 6 (3.75 to 9.5) | 8.50 (6.5 to 9.25) |
Collected over Adverse Events were collected from baseline to end of study, approximately 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| B12a | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Placebo | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) |
| Event | B12a | Placebo |
|---|---|---|
| Acute Kidney InjuryRenal and urinary disorders | 0/4 | 2/4 |
| Age, Continuous(years) | B12a | Placebo | Total |
|---|---|---|---|
| Median | 64 (56 to 69) | 70 (64 to 73) | 69 (60 to 69) |
| Sex: Female, Male(Participants) | B12a | Placebo | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 3 | 3 | 6 |
| Ethnicity (NIH/OMB)(Participants) | B12a | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 3 | 3 | 6 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | B12a | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 4 | 3 | 7 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | B12a | Placebo | Total |
|---|---|---|---|
| United States | 4 | 4 | 8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2019 to primary completion in Apr 2022, 35 months.
Results were first posted in May 2023, 1 year 1 month after primary completion.
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This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydroxocobalamin