NCT04008446

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

3.4 years

First QC Date

June 17, 2019

Last Update Submit

January 9, 2023

Conditions

Bacteremia

Outcome Measures

Primary Outcomes (1)

  • Holotranscobalamin (HTC) levels

    HTC levels in patients with infection and sepsis compared to patients with infection without sepsis.

    6 days

Secondary Outcomes (2)

  • Vitamin B12 levels

    6 days

  • Methylmalonic acid (MMA) levels

    6 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Adults (≥18 years old)
  • Infection, confirmed by a positive culture result
  • Signed informed consent.

You may not qualify if:

  • Pregnancy and/or breast feeding
  • Inability to follow the procedures of the study, due to language problems, psychological disorders, social conditions or dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Pregernig A, Held U, Schlapfer M, Beck-Schimmer B. Vitamin B12 status and the risk of developing sepsis in patients with bacterial infection: a prospective observational cohort study. BMC Med. 2024 Aug 13;22(1):330. doi: 10.1186/s12916-024-03552-3.

    PMID: 39134986DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bloodsample

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2019

First Posted

July 5, 2019

Study Start

June 1, 2019

Primary Completion

November 11, 2022

Study Completion

December 31, 2022

Last Updated

January 10, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)