Trial · NCT03735316
Vitamin B12a Vasoplegic Syndrome
NCT03735316, Phase 2, Terminated, Mayo Clinic; results first posted 2023-05-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vitamin B12a Vasoplegic Syndrome. Trials, record NCT03735316. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03735316
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vitamin B12a Vasoplegic Syndrome
- NCT number
- NCT03735316
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Vasoplegic Syndrome
- Interventions
- Hydroxocobalamin, Cardiopulmonary Bypass, Placebos
- First posted
- 2018-11-08
- Last updated
- 2023-05-10
- Results first posted
- 2023-05-10
- Limitations and caveats
- Terminated study. Insufficient recruitment over study period
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean Arterial Pressure | baseline, 4 hours | The average pressure in a patient's arteries during one cardiac cycle |
| Secondary | Change in Norepinephrine Equivalent Infusion Rate. Norepinephrine Equivalent Table is Listed in the Study Protocol | baseline, 4 hours | 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. |
| Secondary | Change in Systolic Blood Pressure | baseline, 4 hours | The maximum arterial pressure during contraction of the left ventricle of the heart. |
| Secondary | Death | 30 days | Number subject deaths |
| Secondary | Duration of Hospital Stay | 30 days | Number of days subjects are hospitalized |
| Secondary | Duration of Intensive Care Stay | 30 days | Number of days subjects are in the intensive care unit |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Mean Arterial Pressure | baseline, 4 hours | Terminated study. Insufficient recruitment over study period | mmHg | MEDIAN |
| SECONDARY | Change in Norepinephrine Equivalent Infusion Rate. Norepinephrine Equivalent Table is Listed in the Study Protocol | baseline, 4 hours | Terminated study. Insufficient recruitment over study period | mcg/kg/min | MEDIAN |
| SECONDARY | Change in Systolic Blood Pressure | baseline, 4 hours | Terminated study. Insufficient recruitment over study period | mmHg | MEDIAN |
| SECONDARY | Death | 30 days | Terminated study. Insufficient recruitment over study period | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Hospital Stay | 30 days | Terminated study. Insufficient recruitment over study period | days | MEDIAN |
| SECONDARY | Duration of Intensive Care Stay | 30 days | Terminated study. Insufficient recruitment over study period | days | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Arterial Pressure | B12a | 6 | Inter-Quartile Range 1.25 to 9.5 | mmHg | |
| Change in Mean Arterial Pressure | Placebo | -0.5 | Inter-Quartile Range -2.75 to 1.25 | mmHg | |
| Change in Norepinephrine Equivalent Infusion Rate. Norepinephrine Equivalent Table is Listed in the Study Protocol | B12a | -0.035 | Inter-Quartile Range -0.0625 to -0.0150 | mcg/kg/min | |
| Change in Norepinephrine Equivalent Infusion Rate. Norepinephrine Equivalent Table is Listed in the Study Protocol | Placebo | 0.02 | Inter-Quartile Range 0.0075 to 0.0425 | mcg/kg/min | |
| Change in Systolic Blood Pressure | B12a | 5.5 | Inter-Quartile Range -0.5 to 9.75 | mmHg | |
| Change in Systolic Blood Pressure | Placebo | 0.5 | Inter-Quartile Range -1.25 to 1.25 | mmHg | |
| Death | B12a | 0 | Participants | ||
| Death | Placebo | 0 | Participants | ||
| Duration of Hospital Stay | B12a | 11.5 | Inter-Quartile Range 8 to 16.5 | days | |
| Duration of Hospital Stay | Placebo | 15 | Inter-Quartile Range 12.5 to 18.0 | days |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | B12a | 4 | |
| Overall Study | STARTED | Placebo | 4 | |
| Overall Study | COMPLETED | B12a | 4 | |
| Overall Study | COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | B12a | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Acute Kidney Injury | Renal and urinary disorders | B12a | 0 | 4 | |
| other | Acute Kidney Injury | Renal and urinary disorders | Placebo | 2 | 4 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | B12a | 0 | 4 |
| Total, all-cause mortality | Placebo | 0 | 4 |
| Total, other adverse events | B12a | 0 | 4 |
| Total, other adverse events | Placebo | 2 | 4 |
| Total, serious adverse events | B12a | 0 | 4 |
| Total, serious adverse events | Placebo | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| B12a vs Placebo: Death | Trial comparisons |
| B12a vs Placebo: deaths from any cause | Trial comparisons |
| B12a vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03735316
GET https://conductscience.org/api/trials/v1/NCT03735316/registered