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A Randomised Controlled Trial to find out the optimal maintenance fluid in children with very severe pneumonia

Isotonic(0.9% NS) versus Hypotonic(0.18% NS) parenteral maintenance fluids in children with very severe pneumonia: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/02/003398
Enrollment
112
Registered
2013-02-15
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: null- Children with very severe pneumonia

Interventions

Intervention1: Isotonic Fluid: 0.9 % saline as parenteral maintenance fluid according to Holliday Segar formula up till a period of 24 hours. Control Intervention1: Hypotonic Fluid: 0.18 % as parenter

Sponsors

Lady Hardinge Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Fever with cough with fast breathing and chest indrawing with nasal flaring or grunting plus at least one of the following Central cyanosis Inability to breastfeed or drink or vomiting everything Convulsions lethargy or Unconsciousness Severe respiratory distress

Exclusion criteria

Exclusion criteria: Meningitis Encephalitis Congestive cardiac failure Known Renal disease Chronic Liver Disease Shock at presentation Severe acute malnutrition Known endocrinal disease Refusal of consent

Design outcomes

Primary

MeasureTime frame
Proportion of patients developing hyponatremia that is serum sodium less than 135 mmol per litre after receiving intravenous maintenance fluids.Timepoint: At 6 hours At 12 hours At 24 hours

Secondary

MeasureTime frame
Proportion of patients developing clinically symptomatic hyponatremia Timepoint: At 6 hours At 12 hours At 24 hours;Proportions of patients developing hypernatremia that is serum sodium more than 150 mmol per litreTimepoint: At 6 hours At 12 hours At 24 hours

Countries

India

Contacts

Public ContactDr Praveen Kumar

Department of Pediatrics Lady Hardinge Medical College

pkpaed@gmail.com09868579672

Outcome results

None listed

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