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

Assessment of the vitamin B1 effect on the outcomes of patients with sepsis under mechanical ventilation admitted to the general intensive care unit

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220711055432N1

Enrollment

Registered

2022-09-10

Start date

2022-09-23

Completion date

Unknown

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis. Other sepsis

Interventions

Intervention 1: Intervention group: Patients will receive oral vitamin B1 tablets (300 mg) on the second day of mechanical ventilation for up to 7 days in addition to routine treatments. The drug will

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad Amin Valizad Hasanlouei

Oroumia University of Medical Sciences

valizadeh.ma@umsu.ac.ir+98 44 3345 7286

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026