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IRCT20200825048515N61 IRCT 2022-10-14 Esfahan University of Medical Sciences The effectiveness of vitamin C and thiamine administration method in the improvement and prognosis of shock patients 1 month to 15 years 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 2022-09-22 anticipated 270 Complete https://irct.ir/trial/65746 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Shock. Intervention 1: 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 admission to the PICU. Intervention 2: 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. Intervention 3: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Nazanin Zibanejad
Department of Pediatrics, Imam Hossein Hospital, Imam Khomeini Street.
Isfahan Iran (Islamic Republic of) 8195163381 +98 31 3386 6266 zibanejadn@gmail.com Esfahan University of Medical Sciences scientific Nazanin Zibanejad
Department of Pediatrics, Imam Hossein Hospital, Imam Khomeini Street.
Isfahan Iran (Islamic Republic of) 8195163381 +98 31 3386 6266 zibanejadn@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Children from 1 month to 15 years Suffering from shock (other than obstructive shock) Need vasopressors to maintain at least 5% of blood pressure percentile for age Parents' consent to participate in the study 1 month 15 years Both Having active gastrointestinal bleeding R57.9 Shock, unspecified Treatment - Drugs Treatment - Drugs Placebo 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 admission to the 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. The amount of Vasopressor requirement. Timepoint: During the intervention. Method of measurement: Number of vasopressor injections. Ventilator requirement. Timepoint: During the intervention. Method of measurement: PaCo2<50% and pH<7.3. Blood Creatinine. Timepoint: In the first four days of hospitalization. Method of measurement: Blood test. C-reactive protein (CRP). Timepoint: In the first four days of hospitalization. Method of measurement: Blood test. White blood cell. Timepoint: In the first four days of hospitalization. Method of measurement: Blood test. Lactate. Timepoint: In the first four days of hospitalization. Method of measurement: Blood test. Isfahan University of Medical Sciences Approved 2022-01-20 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)