Condition 1: Sepsis. Condition 2: Severe sepsis with septic shock. Other sepsis Severe sepsis with septic shock
Conditions
Interventions
Intervention 1: Intervention group: Take 100 mg of thiamine per day orally (oral or gavage) for 7 days. Intervention 2: Control group: Not receiving thiamine and continuing standard sepsis treatment a
Sponsors
Karaj University of Medical Sciences
Eligibility
Sex/Gender
All
Age
3 Months to 18 Years
Inclusion criteria
Inclusion criteria: Age over 3 months and under 18 years Diagnosis of sepsis based on SIRS criteria Hospitalization in the emergency service or PICU
Exclusion criteria
Exclusion criteria: Patients completing a course of chemotherapy or radiotherapy. Patients with a diagnosis other than infection, including lymphoma, for fever and leukocytosis. Children with congenital immunological defects including: CVID – SCID – complement deficiency and serum immunoglobulin deficiency Children with any of the clinical malnutrition syndromes that cause a significant reduction in thiamine levels in their body. Children with any congenital metabolic defect that causes thiamine deficiency. Or also patients with congenital metabolic disorders that cause increased blood lactate levels (such as galactosemia). Children with digestive diseases, including Crohn's and ulcerative colitis, which interfere with thiamine absorption. Children with chronic heart failure Children with chronic kidney failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in SOFA (Sequential Organ Failure Assessment) score. Timepoint: The primary outcome of this study is the change in the SOFA (Sequential Organ Failure Assessment) score as an indicator of the severity of organ failure in children with sepsis. The SOFA score will be recorded as a baseline value at the beginning of the patient's entry into the study (simultaneously with the diagnosis of sepsis and before the start of the intervention). Then, subsequent measurements of the SOFA score will be performed daily on the first, third, and seventh days after the start of the intervention. In patients who are discharged from the hospital or die before the seventh day, the last recorded SOFA score will be included as the final value in the analyses. These time points allow for the assessment of the change in the severity of the disease and the comparison of the effect of the intervention between the two study groups. Method of measurement: The primary outcome of this study is the severity of organ failure in children with sepsis, measured using the Sequential Organ Failure Assessment Score. This tool is a standardized and validated clinical index that is calculated based on the patient's clinical and laboratory data, including respiratory status, cardiovascular system, renal function, hepatic function, coagulation status, and level of consciousness. The information required to calculate the score for this scale is extracted from the patient's medical record, routine test results, and vital signs recorded by the treatment team, and the final score will be calculated and recorded by the investigator in charge of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of hospitalization. Timepoint: From the time the patient is admitted to the hospital with a diagnosis of sepsis until the time the patient is discharged from the hospital or dies, whichever occurs first. Method of measurement: The length of hospitalization in days is calculated and recorded based on the recorded date and time of admission, discharge, or death of the patient in the medical record.;Length of stay in the pediatric intensive care unit. Timepoint: From the time the patient is transferred to the pediatric intensive care unit until the time the patient is transferred to the regular ward, discharged from the hospital, or dies. Method of measurement: The length of stay in the pediatric intensive care unit in days is calculated and recorded using information recorded in the patient's clinical record.;Need to use mechanical ventilation. Timepoint: Throughout the patient's entire hospital stay, from study entry to discharge or death. Method of measurement: The need for mechanical ventilation is determined and recorded in the patient's file as a binary variable (needed or not needed), as well as the duration of use in days, based on medical orders and clinical records.;Need to use vasopressor medications. Timepoint: Throughout the entire hospital stay, from the time of diagnosis of sepsis until discharge or death. Method of measurement: The need for vasopressor medication is assessed as a dichotomous variable (received or not) and the duration of medication in days, based on treatment orders and medication records recorded in the patient's medical record.;Mortality rate. Timepoint: During the patient's hospital stay, from the time of study entry until discharge or death. Method of measurement: Mortality is determined and recorded based on the patient's final status (alive or deceased) in the medical record and official hospital report. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatemeh AghaMahdi
Karaj University of Medical Sciences
Outcome results
None listed