NCT03783091 (B12) is a Phase 2 clinical trial of Hydroxocobalamin in Septic Shock, sponsored by Medical College of Wisconsin.

Who is sponsoring NCT03783091?

NCT03783091 is sponsored by Medical College of Wisconsin.

What drugs are being tested in NCT03783091?

Interventions in NCT03783091: Hydroxocobalamin, Placebo.

What condition does NCT03783091 study?

NCT03783091 studies Septic Shock.

Is NCT03783091 still recruiting?

NCT03783091 is currently completed. Last updated 27 November 2024.

Last reviewed 2024-11-27 · How we verify

NCT03783091: B12

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Trial of Vitamin B12 in Septic Shock

Completed Phase 2 Last updated 27 November 2024

What this trial tests

Phase 2 trial testing Hydroxocobalamin in Septic Shock in 20 participants. Completed in 23 February 2023.

Timeline

5 August 2019

Primary endpoint
23 February 2023

23 February 2023

Quick facts

Lead sponsor	Medical College of Wisconsin
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	20
Start date	5 August 2019
Primary completion	23 February 2023
Estimated completion	23 February 2023
Sites	1 location across United States

Drugs / interventions tested

Hydroxocobalamin (HYDROXOCOBALAMIN) — full drug profile →
Placebo

Conditions studied

Septic Shock — all drugs for Septic Shock →

Sponsor

Medical College of Wisconsin

Who can join

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

Sponsor's own description

This study will randomize 20 septic shock patients to receive either a single 5 gram dose of IV vitamin B12 (Cyanokit® Meridian Medical Technologies, Columbia, MD) versus placebo in addition to standard of care to test the feasibility of completing clinical and laboratory protocols.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

High-Dose IV Hydroxocobalamin (Vitamin B12) in Septic Shock: A Double-Blind, Allocation-Concealed, Placebo-Controlled Single-Center Pilot Randomized Controlled Trial (The Intravenous Hydroxocobalamin in Septic Shock Trial).
Patel JJ, Willoughby R, Peterson J, Carver T, et al · · 2023 · cited 30× · PMID 36174744 · DOI 10.1016/j.chest.2022.09.021
Vitamin therapy in sepsis.
Wald EL, Badke CM, Hintz LK, Spewak M, et al · · 2022 · cited 22× · PMID 34333556 · DOI 10.1038/s41390-021-01673-6
Hydroxocobalamin in Refractory Septic Shock: A Retrospective Case Series.
Sacco AJ, Cunningham CA, Kosiorek HE, Sen A. · · 2021 · cited 11× · PMID 33912838 · DOI 10.1097/cce.0000000000000408

Verify or expand the search:

Other trials of Hydroxocobalamin

Trials testing the same drug.

NCT07469189 — A Study on Hydroxocobalamin Given to Healthy Individual to Monitor Symptoms · Phase 1 · completed
NCT04054999 — Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients · Phase 4 · completed
NCT03735316 — Vitamin B12a Vasoplegic Syndrome · Phase 2 · terminated

Other recruiting trials for Septic Shock

Currently open trials in the same condition.

NCT07179276 — Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock · NA · recruiting
NCT07383103 — Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock · Phase 4 · recruiting
NCT07419802 — OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study · recruiting
NCT07264543 — Early Methylene Blue in the Microhemodynamics of Septic Patients · Phase 2, PHASE3 · recruiting
NCT04855786 — External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients · NA · recruiting

Other Medical College of Wisconsin trials

Trials by the same sponsor.

NCT07260552 — Rapid Engagement for Solutions to Population and Outcomes Through Networked Dialogue for Coronary Heart Disease · not yet recruiting
NCT06795360 — Weight Changes After Incretin-mimetics · NA · not yet recruiting
NCT07228208 — Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes · NA · not yet recruiting
NCT07298460 — Stimulation-based Therapy to Improve Balance in DCM · Phase 1, PHASE2 · not yet recruiting
NCT07434544 — Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D) · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03783091 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medical College of Wisconsin
Last refreshed: 27 November 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03783091.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing