Comparing Saline And Half Saline as Intravenous Maintenance Fluid In Children 1 Month To 1 Year Of Age

Phase 1

• Conditions: Health Condition 1: R798- Other specified abnormal findingsof blood chemistry

• Registration Number: CTRI/2020/03/023778
• Lead Sponsor: amphrang Nongtri

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

All infants between 1 month to 1 year of age,hospitalized and who need maintenance intravenous fluid for atleast 24 hours

Exclusion Criteria

1. Signs of dehydration or shock at

presentation

2. Severe acute malnutrition( weight for

height <-3 S.D as per WHO standard)

3. Children with congestive heart failure,renal

failure,cirrhosis of liver,nephrotic

syndrome,severe burns,raised intracranial

pressure,suspected case of diabetes

mellitus,diabetes insipidus and congenital

adrenal hyperplasia.

4. Children who are receiving drugs that alter

plasma sodium levels such as

furosemide,vasopressin and mannitol.

5. Surgical(post operative) patients and those

with neurosurgical disorders.

6. Children who have received IV fluid therapy

prior to hospitalization to our hospital.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be incidence of hyponatraemia(defined as serum sodium level less than 130mEq/L),24 hours after initiation of therapy.Timepoint: 24 hours

Secondary Outcome Measures

Name	Time	Method
1.Mean serum sodium level 24 hours after initiation of therapy <br/ ><br>2.Development of hypernatremia,defined as serum sodium level more than 150 mEq/L <br/ ><br>3.Acid base abnormalities(metabolic acidosis and metabolic alkalosis) <br/ ><br>4.Signs of fluid overload.Timepoint: 24 hours