]>
IRCT20210201050199N2 IRCT 2023-08-26 Rasht University of Medical Sciences Evaluation of therapeutic outcome of ringer lactate in treatment of acute resuscitation phase of severe dehydration children a randomized clinical trial Evaluation of therapeutic outcome of ringer lactate in treatment of acute resuscitation phase of severe dehydration children a randomized clinical trial 2023-08-23 anticipated 104 Complete https://irct.ir/trial/71887 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into two groups of 52 people. The sampling method of this study is in the form of gradual sampling (consequential sampling). Thus, according to the referrals of children to 17 Shahrivar Hospital with complaints of diarrhea and having entry criteria, they are placed in groups A (Ringer's Lactate) and B (Normal Saline). The method of allocating children in the two respective groups is based on quadruple random blocks, and the sequence of selecting the samples will be done through the Random Allocation software. The varnished and sealed letter is kept hidden. After reading the list, the children will be placed in two groups A and B based on the sequence of this list, Blinding description: In this triple-blind study, the patient and the researcher were blind regarding the use of unlabeled serums which were titled A and B. Also, the data analyst will be blind to the assigned groups and analyze data as A and B. Notably. the label of the serum type was removed by a non-collaborating nurse in the plan and identified as groups A and B. 3 Dehydration. Intervention 1: Intervention group: 20 cc of Ringer's serum lactate will be injected intravenously as a bolus liquid per kilogram of weight. After initial resuscitation, patients were treated with dextrose saline serum as a maintenance fluid. Intervention 2: Control group: 20 cc of normal saline fluid per kilogram of body weight will be administered through the peripheral vein as a bolus liquid, and if there is no improvement in the signs and symptoms of dehydration, the second and third dose of normal saline will be administered with the same dose. No - There is not a plan to make this available Justification or reason for not sharing IPD is Ethical issues
public Manijeh Tabrizi
Siadati
Rasht Iran (Islamic Republic of) 4167811969 +98 13 3336 9002 drs.tabrizi@gmail.com Rasht University of Medical Sciences scientific Manijeh Tabrizi
Siadati
Rasht Iran (Islamic Republic of) 4167811969 +98 13 3336 9002 drs.tabrizi@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Severe dehydration Age 30 days to 14 years 30 days 14 years Both Severe and acute malnutrition Duration of diarrhea more than 7 days The presence of blood in the stool underlying systemic disease Receiving Ringer's serum or normal saline in the last 24 hours Electrolyte disorder such as hypo or hypernatremia in the initial tests of the patient Occurrence of seizures during hospitalization X54 Lack of water Treatment - Other Treatment - Other Intervention group: 20 cc of Ringer's serum lactate will be injected intravenously as a bolus liquid per kilogram of weight. After initial resuscitation, patients were treated with dextrose saline serum as a maintenance fluid. Control group: 20 cc of normal saline fluid per kilogram of body weight will be administered through the peripheral vein as a bolus liquid, and if there is no improvement in the signs and symptoms of dehydration, the second and third dose of normal saline will be administered with the same dose. Primary outcome: comparison of the time for the disappearance of symptoms of severe dehydration. Timepoint: At the beginning and six hours after the start of treatment. Method of measurement: Clinical examination. Time to resolve acidosis. Timepoint: At the beginning and six hours after the start of treatment. Method of measurement: blood test. Rasht University of Medical Sciences Approved 2023-07-12 Ethics committee of the vice chancellor of Guilan University of Medical Sciences Siadati rasht Guilan Iran (Islamic Republic of)