Investigating the vitamin C and thiamine administration method with the usual method in the improvement and prognosis of shock patients 1 month to 15 years

Determining and comparing the effect of vitamin C and thiamine administration method with the usual method in the improvement and prognosis of shock patients one month to 15 years

A randomized, double-blinding clinical trial, with parallel groups, Phase 3 on 270 patients

In this randomized double-blind clinical trial study, 270 eligible patients referred to Imam Hossein Hospital of Isfahan will be included in the study and will be randomly divided into three groups. In the first, second, and third groups, "vitamin c", "thiamine" and "normal saline" are prescribed respectively. Then, the need for a vasopressor and a ventilator, and the level of blood parameters of the patients will be evaluated and compared among the three groups.

The inclusion criteria include children 1 month to15 years old, suffering from shock, needing vasopressors to maintain at least 5% blood pressure percentile for age, and parental consent to participate in the study. Exclusion criteria include active gastrointestinal bleeding.

The first intervention group: For patients in this group, vitamin C medicine will be prescribed at a dose of 30 mg/kg every 6 hours up to a maximum of 1500 mg/dose for 4 days or until hospitalization in PICU. The second intervention group: For patients in this group, oral thiamine medicine will be prescribed at a dose of 4 mg/kg every 12 hours up to a maximum of 200 mg/kg/dose for 4 days or until admission to the PICU. Control group: For patients in this group, normal saline with the same volume and form of the study drugs will be prescribed with the same protocol.

Vasopressor dose; Ventilator requirement; Blood Creatinine level; white blood cell level; C-reactive protein or CRP level; Lactate level

Before starting the study, letter A is written on 90 sheets, letter B is written on 90 sheets, and letter C is written on 90 sheets and each is placed in an envelope. Then, the parents of each of the eligible patients who consented to participate in the study are asked to choose an envelope from among the envelopes. In this way, the patient will be randomly assigned to one of the three groups according to the envelope selected without the interference of the researcher.

In order to comply with the conditions of double-blindness of the study, vitamin C, thiamine, and placebo were prepared by the pharmacist in the same shape, color, and size before the study (without the researcher's knowledge) and are placed in the same packaging and with A, B, C codes are labeled. Then the drugs are provided to the researcher and the researcher will prescribe them in the same way without knowing the type of drug. Therefore, the patient, care provider, investigator, outcome assessor, and data analyzer will not be aware of the type of intervention.

There is no further information