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Fluid therapy in critically sick children

Restrictive versus standard maintenance fluid therapy to prevent fluid overload in children admitted in paediatric intensive care unit: A single-centre, randomized, single-blinded, controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/035006
Enrollment
100
Registered
2021-07-20
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: R69- Illness, unspecified Health Condition 2: R652- Severe sepsis Health Condition 3: R579- Shock, unspecified Health Condition 4: R651- Systemic inflammatory response syndrome (SIRS) of non-infectious origin

Interventions

Intervention1: RESTRICTIVE MAINTENANCE FLUID THERAPY: Restricting maintenance fluid therapy to 50% as estimated by Holliday-Segar Formula Control Intervention1: STANDARD MAINTENANCE FLUID THERAPY: Sta

Sponsors

AIIMS Patna
Lead Sponsor
INDIAN COUNCIL OF MEDICAL RESEARCH
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Any child admitted to PICU, AIIMS Patna, anticipated to be admitted for at least 48 hours, who is planned to be prescribed >50% maintenance fluids intravenously.

Exclusion criteria

Exclusion criteria: Clinical conditions requiring specific maintenance fluid regimens or where restricting fluids may be unethical or which may act as confounders in fluid status assessment: a. Children below the age of 28 days (neonates) b. Congenital heart disease, myocarditis, cardiomyopathy c. Diabetic ketoacidosis (DKA) d. Diabetes insipidus (DI) e. Diarrhoea with severe dehydration f. Acute and chronic renal failure requiring renal replacement therapy at presentation g. Nephrotic syndrome h. Burns

Design outcomes

Primary

MeasureTime frame
Peak fluid overload defined as (total input-total output)/admission weight X 100.Timepoint: Daily till 3 days of PICU stay and then one reading after 72 hours till day 7 of PICU stay—

Secondary

MeasureTime frame
Survival or deathTimepoint: 28 days from PICU admission—

Countries

India

Contacts

Public ContactPRAKRITI GUPTA

DEPARTMENT OF PAEDIATRICS, AIIMS PATNA

lokeshdoc@yahoo.com9631638095

Outcome results

None listed

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