Assessment of the vitamin B1 effect on the outcomes of patients with sepsis

Phase 3

Recruiting

• Conditions: Sepsis.; Other sepsis

• Registration Number: IRCT20220711055432N1
• Lead Sponsor: Oroumia University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Sepsis patients
Patients under mechanical ventilation for at least 24 hours
Age above 18 years

Exclusion Criteria

Renal failure with a GFR of less than 15
Vitamin B1 consumption during the last 15 days before hospitalization
Hospitalization less than 4 days in ICU
Having an indication for the administration of vitamin B1, such as alcohol poisoning

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation. Timepoint: during a week after the intervention. Method of measurement: Days.;The Sequential Organ Failure Assessment (SOFA) Score. Timepoint: Before intervention and 1st, 3rd and 7th day after the intervention. Method of measurement: The Sequential Organ Failure Assessment (SOFA) index.;Acute Physiology and Chronic Health Evaluation (APACHE) II score. Timepoint: Before intervention and 1st, 3rd and 7th day after the intervention. Method of measurement: Acute Physiology and Chronic Health Evaluation (APACHE) II queationnaire.

Secondary Outcome Measures

Name	Time	Method
White blood cell count (WBC). Timepoint: Before intervention and the 1st, 3rd and 7th day after the intervention. Method of measurement: Cell counter.;Erythrocyte sedimentation rate (ESR). Timepoint: Before intervention and the 1st, 3rd and 7th day after the intervention. Method of measurement: Flow Cytometry.;C-reactive protein (CRP). Timepoint: Before intervention and the 1st, 3rd and 7th day after the intervention. Method of measurement: Elisa test.;Lactate dehydrogenase (LDH). Timepoint: Before intervention and the 1st, 3rd and 7th day after the intervention. Method of measurement: Elisa test.;Neutrophil to lymphocyte ratio. Timepoint: Before intervention and the 1st, 3rd and 7th day after the intervention. Method of measurement: Blood sample.;Mortality. Timepoint: During hospitalization and 28 days after intervention. Method of measurement: Medical record/ phone call.