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

Isotonic (0.9% NaCl) Versus Half Isotonic (0.45% NaCl) Fluid as Intravenous Maintenance Fluid in Infants: An Open Label Randomized Controlled Study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023778
Enrollment
164
Registered
2020-03-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Intravenous Fluids Administration: Subjects will be allocated either of the two maintenance fluids (isotonic:0.9% NaCl with 5% dextrose OR hypotonic fluid: 0.45% NaCl with 5% dextrose)

Sponsors

Lamphrang Nongtri
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Signs of dehydration or shock at presentation 2. Severe acute malnutrition( weight for height 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.

Design outcomes

Primary

MeasureTime frame
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

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

Countries

India

Contacts

Public ContactLamphrang Nongtri

Head of Department Pediatrics, Mentor

prof.piyush.gupta@gmail.com9811597172

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026