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

January 9, 2023 updated by: University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital of Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who present to the ED with suspicion of infection, and for whom microbiological cultures are indicated,can to be enrolled into the study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Holotranscobalamin (HTC) levels
Time Frame: 6 days
HTC levels in patients with infection and sepsis compared to patients with infection without sepsis.
6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin B12 levels
Time Frame: 6 days
Levels of vitamin B12 in patients with infection and sepsis compared to patients with infection without sepsis
6 days
Methylmalonic acid (MMA) levels
Time Frame: 6 days
Levels of ethylmalonic acid (MMA) in patients with infection and sepsis compared to patients with infection without sepsis
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

November 11, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

June 17, 2019

First Submitted That Met QC Criteria

July 3, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-00702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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