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To compare safety and efficacy of fluid administration in severe acute malnutritioned children with diarrhea and shock at two different rates.

Efficacy and Safety of two regimens of fluid administration in children aged 2-59 months with severe acute malnutrition with diarrhea and shock - A Randomized Controlled Trail

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/07/020220
Enrollment
84
Registered
2019-07-16
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: E43- Unspecified severe protein-caloriemalnutrition

Interventions

Intervention1: 30 ml/kg: Patients in Group A: 30 ml/kg of half Normal Saline with 5% glucose over 1 hour. Control Intervention1: 15 ml/kg: GROUP B: 15 ml/kg of half Normal Saline with 5% glucose over

Sponsors

Dr Vineeta Singh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children aged 2 months to 5 years attending Kalawati Saran Childrens hospital with diarrhoea, 1.Meeting case definition of severe acute malnutrion and 2.diarrhea and 3.shock

Exclusion criteria

Exclusion criteria: 1. History of recieving IV fluids before admission 2. Known renal(nephrotic syndrome, chronic kidney disease) and heart disease(congenital heart disease) 3. History of not passed urine more than 6 hours.

Design outcomes

Primary

MeasureTime frame
1.Proportion of children showing reversal of shock at 1 hour.Timepoint: 1.Proportion of children showing reversal of shock at 1 hour.

Secondary

MeasureTime frame
1. Proportion of children developing signs of over hydration or congestive heart failure. 2. Proportion of children successfully discharged. 3. Proportion of children with adverse outcomes. 4. mean length of stay in hospital.Timepoint: Till discharge

Countries

India

Contacts

Public ContactDr Vineeta Singh

Lady Hardinge medical college and Associated Hospitals

drvkumar1@gmail.com9313985662

Outcome results

None listed

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