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Insufficient recruitment over study period
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B12a | Experimental | Subjects will receive Hydroxocobalamin marketed as Cyanokit®, 5g, IV |
|
| Placebo | Placebo Comparator | Subjects will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxocobalamin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Arterial Pressure | The average pressure in a patient's arteries during one cardiac cycle | baseline, 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James A. Nelson, M.B.B.S. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Saint Mary's Hospital | Rochester | Minnesota | 55902 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Arterial Pressure | The average pressure in a patient's arteries during one cardiac cycle | Terminated study. Insufficient recruitment over study period | Posted | Median | Inter-Quartile Range | mmHg | baseline, 4 hours |
|
Adverse Events were collected from baseline to end of study, approximately 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
Terminated study. Insufficient recruitment over study period
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James A. Nelson, M.B.B.S. | Mayo Clinic | 480-342-1800 | Nelson.James1@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 3, 2021 | May 6, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D056987 | Vasoplegia |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D006879 | Hydroxocobalamin |
| D014805 | Vitamin B 12 |
| D002315 | Cardiopulmonary Bypass |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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Masking and blinding will be carried out by the research pharmacy with unmasking to be performed at study completion through the research pharmacy and statistician.
|
| Cardiopulmonary Bypass | Procedure | 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 | Drug | 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 | The maximum arterial pressure during contraction of the left ventricle of the heart. | baseline, 4 hours |
| Death | Number subject deaths | 30 days |
| Duration of Hospital Stay | Number of days subjects are hospitalized | 30 days |
| Duration of Intensive Care Stay | Number of days subjects are in the intensive care unit | 30 days |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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. |
|
|
| Secondary | 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. | Terminated study. Insufficient recruitment over study period | Posted | Median | Inter-Quartile Range | mcg/kg/min | baseline, 4 hours |
|
|
|
| Secondary | Change in Systolic Blood Pressure | The maximum arterial pressure during contraction of the left ventricle of the heart. | Terminated study. Insufficient recruitment over study period | Posted | Median | Inter-Quartile Range | mmHg | baseline, 4 hours |
|
|
|
| Secondary | Death | Number subject deaths | Terminated study. Insufficient recruitment over study period | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Duration of Hospital Stay | Number of days subjects are hospitalized | Terminated study. Insufficient recruitment over study period | Posted | Median | Inter-Quartile Range | days | 30 days |
|
|
|
| Secondary | Duration of Intensive Care Stay | Number of days subjects are in the intensive care unit | Terminated study. Insufficient recruitment over study period | Posted | Median | Inter-Quartile Range | days | 30 days |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 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. | 0 | 4 | 0 | 4 | 2 | 4 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |