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NCT04008446 Clinical Trial

Effect of Vitamin B12 on the Development of Sepsis, in Culture Positive Patients

Bacteremia Clinical Trial

— Vit B12  

Official title:
Effect of Vitamin B12 on the Development of Sepsis, in Culture Positive Patients : an Observational Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04008446
Other study ID # 2019-00702
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date December 31, 2022

Study information
Verified date January 2023
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an prospective observational study assessing the effect of vitamin B12 on the odds of developing sepsis in patients with infection confirmed by a positive culture result. The hypothesis is that patients with infection confirmed by positive cultures who develop sepsis have lower vitamin B12 levels than patients infection, confirmed by positive cultures, who do not develop sepsis.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 31, 2022
Est. primary completion date November 11, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults (=18 years old) - Infection, confirmed by a positive culture result - Signed informed consent. Exclusion Criteria: - Pregnancy and/or breast feeding - Inability to follow the procedures of the study, due to language problems, psychological disorders, social conditions or dementia

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland University Hospital of Zurich Zurich

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Holotranscobalamin (HTC) levels HTC levels in patients with infection and sepsis compared to patients with infection without sepsis. 6 days
Secondary Vitamin B12 levels Levels of vitamin B12 in patients with infection and sepsis compared to patients with infection without sepsis 6 days
Secondary Methylmalonic acid (MMA) levels Levels of ethylmalonic acid (MMA) in patients with infection and sepsis compared to patients with infection without sepsis 6 days
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