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Completed

NCT Number: NCT04008446

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

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.

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Key information

Conditions

Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Holotranscobalamin (HTC) levels

    Time frame: 6 days

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

Secondary outcomes

  1. Vitamin B12 levels

    Time frame: 6 days

    Levels of vitamin B12 in patients with infection and sepsis compared to patients with infection without sepsis

  2. 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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: Vit B12

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 5, 2019
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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