Vitamin B12a Vasoplegic Syndrome

NCT03735316 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 17-011130
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vasoplegic Syndrome

Keywords

Vitamin B12a; Hypotension; Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

• Change in Mean Arterial Pressure

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

  baseline, 4 hours

Secondary Outcomes (5)

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

  baseline, 4 hours

• Change in Systolic Blood Pressure

  baseline, 4 hours

• Death

  30 days

• Duration of Hospital Stay

  30 days

• Duration of Intensive Care Stay

  30 days

Study Arms (2)

B12a

EXPERIMENTAL

Subjects will receive Hydroxocobalamin marketed as Cyanokit®, 5g, IV

Drug: Hydroxocobalamin; Procedure: Cardiopulmonary Bypass

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo

Procedure: Cardiopulmonary Bypass; Drug: Placebos

Interventions

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.

Also known as: Cyanokit®, Vitamin B12a

B12a

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.

Also known as: CPB

B12a; Placebo

Placebos DRUG

Placebo is a Normal Saline, 5g, IV, Infused once over 15 minutes. The placebo comes in a 250ml glass vial.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient for whom we are able to obtain consent ahead of their procedure
• Patients presenting for a procedure in which cardiopulmonary bypass will be required
• Considered high risk for vasoplegic syndrome
• Has no contraindications to arterial line or PA catheter placement
• Develops high-dose vasopressors for 30 min or longer and refractory hypotension consistent with vasoplegic syndrome within 24 hours of coming off cardiopulmonary bypass.

You may not qualify if:

• Age\<18 years
• Known pregnancy or patients without a documented pregnancy test if not menopausal.
• Known prior anaphylactic or allergic reaction to B12a
• CKD stage 4 or worse
• ECMO (extracorporeal membrane oxygenation) prior to study consent.
• Patients currently on cardiopulmonary bypass

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Saint Mary's Hospital

Rochester, Minnesota, 55902, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Vasoplegia; Hypotension

Interventions

Hydroxocobalamin; Vitamin B 12; Cardiopulmonary Bypass

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Extracorporeal Circulation; Surgical Procedures, Operative

Limitations and Caveats

Terminated study. Insufficient recruitment over study period

Results Point of Contact

• Title: James A. Nelson, M.B.B.S.
• Organization: Mayo Clinic

Nelson.James1@mayo.edu

480-342-1800

Study Officials

• James A. Nelson, M.B.B.S.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 8, 2018
• Study Start: April 25, 2019
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: May 10, 2023
• Results First Posted: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)