NCT03735316

Vitamin B12a Vasoplegic Syndrome

Terminated Phase 2 Results posted Last updated 10 May 2023

What this trial tests

Phase 2 trial testing Hydroxocobalamin in Vasoplegic Syndrome in 8 participants. Terminated before completion.

Timeline

25 April 2019

Primary endpoint
1 April 2022

1 April 2022

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	8
Start date	25 April 2019
Primary completion	1 April 2022
Estimated completion	1 April 2022
Sites	1 location across United States

Drugs / interventions tested

• Hydroxocobalamin (HYDROXOCOBALAMIN) — full drug profile →
• Cardiopulmonary Bypass
• Placebos — full drug profile →

Conditions studied

• Vasoplegic Syndrome — all drugs for Vasoplegic Syndrome →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Vasoplegic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Mean Arterial Pressure Primary · baseline, 4 hours

The average pressure in a patient's arteries during one cardiac cycle

Group	Value	95% CI
B12a	6	1.25 – 9.5
Placebo	-0.5	-2.75 – 1.25

Change in Norepinephrine Equivalent Infusion Rate. Norepinephrine Equivalent Table is Listed in the Study Protocol Secondary · 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.

Group	Value	95% CI
B12a	-0.035	-0.0625 – -0.0150
Placebo	0.02	0.0075 – 0.0425

Change in Systolic Blood Pressure Secondary · baseline, 4 hours

The maximum arterial pressure during contraction of the left ventricle of the heart.

Group	Value	95% CI
B12a	5.5	-0.5 – 9.75
Placebo	0.5	-1.25 – 1.25

Death Secondary · 30 days

Number subject deaths

Group	Value	95% CI
B12a	0
Placebo	0

Duration of Hospital Stay Secondary · 30 days

Number of days subjects are hospitalized

Group	Value	95% CI
B12a	11.5	8 – 16.5
Placebo	15	12.5 – 18.0

Duration of Intensive Care Stay Secondary · 30 days

Number of days subjects are in the intensive care unit

Group	Value	95% CI
B12a	6	3.75 – 9.5
Placebo	8.50	6.5 – 9.25

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events were collected from baseline to end of study, approximately 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

B12a

Serious: 0/4 (0%)

Deaths: 0/4

Placebo

Serious: 0/4 (0%)

Deaths: 0/4

Other adverse events (1 terms — click to expand)

Reaction	System	B12a	Placebo
Acute Kidney Injury	Renal and urinary disorders	—	—

Data from ClinicalTrials.gov NCT03735316 adverse events section.

Sponsor's own description

The study team will evaluate the medication Hydroxocobalamin (B12a) for treatment of low blood pressure after cardiac surgery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.