Health Condition 1: null- Children 1 month to 12 years with severe dehydration due to acute diarrhea
Conditions
Interventions
Intervention1: Ringers Lactate: Ringers Lactate 100 ml per kg over 6 hours in children less than 1 year or over 3 hours in children 1 to 12 years infused
Control Intervention1: Normal Saline: Normal s
Sponsors
The Director
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 1 month to 12 years diagnosed severe dehydration due to acute diarrhea as per WHO criteria: Acute diarrhea will be defined as more or equal 3 loose or watery or liquid or semiliquid stools in 24 hours. Severe dehydration will be defined as presence of hypotension i.e mean arterial blood pressure less than 5th percentile for age, sex and height or any of the two out of four signs - lethargic or unconscious, sunken eyeballs, drinks poorly or not able to drink, skin pinch goes back very slowly more than 2 seconds)
Exclusion criteria
Exclusion criteria: 1. Duration of diarrhea more than 7 days 2. Bloody diarrhea 3. Severe malnutrition as per WHO criteria (Symmetrical oedema, Weight-for-height: SD-score less than â??3 (less than70%) (Severe wasting)and or Height-for-age: SD-score less than â??3 (less than 85%) (Severe stunting). 4. Known systemic disease (cardiac, endocrine, neurologic, chronic renal failure) 5. Lethal malformations 6. Children who have already received RL or NS during this episode.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correction of severe dehydration in children with acute watery diarrhea, as measured by clinical signs of dehydration and improvement in pHTimepoint: at end of 6 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Length of hospital stayTimepoint: Till discharge from hospital (approximately 5 days);â?¢ The amount of fluid required to correct severe dehydration excluding first cycle of correctionTimepoint: at end of dehydration correction (approximately 12 hours);â?¢ The changes in the serum electrolytes -sodium, potassium, chloride, bicarbonate, base-deficit and anion-gapTimepoint: at end of 6 hours;â?¢ Time taken to start oral feedingTimepoint: at end of dehydration correction (approximately 6 hours) | — |
Countries
India
Contacts
Public ContactDr Ramesh Kumar R
JIPMER
Outcome results
None listed