Evaluation of therapeutic outcome of ringer lactate in treatment of acute resuscitation phase of severe dehydration children a randomized clinical trial

Comparison of the time for the disappearance of symptoms of severe dehydration and the time for correction of acidosis in two groups receiving normal saline and Ringer's lactate.

A clinical trial with the control group, triple blinded, randomized, phase 3, on 104 patients. The random Allocation software is used for randomization.

This is a randomized controlled clinical trial that will be conducted in Rasht 17 Shahrivar Hospital in 1402 on children referred to the emergency department due to severe dehydration caused by acute diarrhea. The sampling method of this study is consecutive.

inclusion criteria: Age between 30 days and 14 years Severe dehydration Exclusion criteria: Severe acute malnutrition, duration of diarrhea more than 7 days, presence of blood in stool, underlying systemic disease, receiving outpatient Ringer's serum or normal saline in the last 24 hours, electrolyte disorder such as hypo or hypernatremia in the patient's initial tests, seizures in the course Hospitalization

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: Time to exit from severe dehydration Secondary outcome: Time to resolve acidosis

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.

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.

Ethical issues