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Vitamin B12 for Septic Shock (B12 Trial)

Phase 2

Recruiting

Led By Jayshil J Patel, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of septic shock, as defined by sepsis-3 criteria

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 24, and 48 hours

Awards & highlights

B12 Trial Summary

This trial will test if a high dose of vitamin B12 can help septic shock patients in addition to standard care.

Who is the study for?

This trial is for adults over 18 with septic shock, admitted to the MICU at Froedtert Hospital and meeting sepsis-3 criteria. It's not for those with a history of calcium oxaluria.Check my eligibility

What is being tested?

The study tests if a single dose of IV vitamin B12 (5 grams) can be feasibly administered alongside standard care in septic shock patients, compared to a placebo group.See study design

What are the potential side effects?

Potential side effects from high-dose vitamin B12 may include skin reactions, diarrhea, blood clots or allergic reactions; however, specific risks will be monitored during the trial.

B12 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with septic shock according to sepsis-3 criteria.

B12 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 24, and 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 24, and 48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 24, and 48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of completing clinical and laboratory protocols

Secondary outcome measures

Change in vasopressor dose

Hydrogen Sulfide Concentration

Mortality

+1 more

B12 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: HydroxocobalaminExperimental Treatment1 Intervention

Single IV infusion administered over a 10-15 minute period

Group II: Saline PlaceboPlacebo Group1 Intervention

Single IV saline administered over a 10-15 minute period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hydroxocobalamin

2014

Completed Phase 4

~50

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,563 Total Patients Enrolled

1 Trials studying Septic Shock

31 Patients Enrolled for Septic Shock

Jayshil J Patel, MDPrincipal InvestigatorMedical College of Wisconsin

1 Previous Clinical Trials

31 Total Patients Enrolled

1 Trials studying Septic Shock

31 Patients Enrolled for Septic Shock

Media Library

Hydroxocobalamin Clinical Trial Eligibility Overview. Trial Name: NCT03783091 — Phase 2

Septic Shock Research Study Groups: Saline Placebo, Hydroxocobalamin

Septic Shock Clinical Trial 2023: Hydroxocobalamin Highlights & Side Effects. Trial Name: NCT03783091 — Phase 2

Hydroxocobalamin 2023 Treatment Timeline for Medical Study. Trial Name: NCT03783091 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what reason is Vitamin B12 generally recommended?

"Hydroxocobalamin is typically used to help burn patients, but it can also aid those with pernicious anemia, vitamin deficiency, and certain behavior disorders."

Answered by AI

Are there any slots left for new participants in this experiment?

"This clinical trial is recruiting participants at this time, according to the latest update on clinicaltrials.gov from 11/30/2021. The original posting for the trial was on 8/5/2019."

Answered by AI

What are the goals of this particular clinical trial?

"The primary focus of this study, to be conducted over the course of 28 days, is assessing the feasibility of completing clinical and laboratory protocols. Additionally, researchers will secondary objectives including changes in vasopressor dose (measured in mcg/kg/min), mortality rates, and hydrogen sulfide concentration levels."

Answered by AI

Are there any known negative side effects of taking Hydroxocobalamin?

"Since there is only evidence of Phase 2 clinical trials for Hydroxocobalamin, which suggests that the medication is effective, our Power team has rated it as a level 2."

Answered by AI

Is there any precedent for using Hydroxocobalamin?

"There are 4 ongoing clinical trials researching the efficacy of hydroxocobalamin. 0 of those live studies are in Phase 3, which is the stage where a drug or treatment is extensively researched for both safety and effectiveness. The many trials for Hydroxocobalamin are based primarily in Milwaukee, Wisconsin, but there are 5 locations running these sorts of tests altogether."

Answered by AI

How many total subjects are a part of this clinical research?

"According to the clinicaltrials.gov website, this study is still looking for volunteers. The trial was first announced on 8/5/2019 with the most recent update being 11/30/2021. They are hoping to enroll a total of 20 patients from 1 location."

Answered by AI

Recent research and studies

Critical Care MedicineJournal

Assessment of the Safety of Recombinant Tissue Factor Pathway Inhibitor in Patients with Severe Sepsis: A Multicenter, Randomized, Placebo-controlled, Single-blind, Dose Escalation Study

Abraham, Edward, Konrad Reinhart, Petr Svoboda, Allan Seibert, Derk Olthoff, Anthony Dal Nogare, Russell Postier, et al.. 2001. “Assessment of the Safety of Recombinant Tissue Factor Pathway Inhibitor in Patients with Severe Sepsis: A Multicenter, Randomized, Placebo-controlled, Single-blind, Dose Escalation Study”. Critical Care Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00003246-200111000-00007.

Clinical ToxicologyJournal

The Vitamin B12 Analog Cobinamide Is an Effective Hydrogen Sulfide Antidote in a Lethal Rabbit Model

Brenner, M., S. Benavides, S. B. Mahon, J. Lee, D. Yoon, D. Mukai, M. Viseroi, et al.. 2014. “The Vitamin B12 Analog Cobinamide Is an Effective Hydrogen Sulfide Antidote in a Lethal Rabbit Model”. Clinical Toxicology. Informa UK Limited. doi:10.3109/15563650.2014.904045.

American Journal of Physiology-Lung Cellular and Molecular PhysiologyJournal

Hydrogen Sulfide Acts as an Inflammatory Mediator in Cecal Ligation and Puncture-induced Sepsis in Mice by Upregulating the Production of Cytokines and Chemokines via Nf-κb

Zhang, Huili, Liang Zhi, Shabbir Moochhala, Philip K. Moore, and Madhav Bhatia. 2007. “Hydrogen Sulfide Acts as an Inflammatory Mediator in Cecal Ligation and Puncture-induced Sepsis in Mice by Upregulating the Production of Cytokines and Chemokines via Nf-κb”. American Journal of Physiology-lung Cellular and Molecular Physiology. American Physiological Society. doi:10.1152/ajplung.00388.2006.

A & A Case ReportsJournal