Intravenous fluid for children with acute diarrhea

Completed

• Conditions: Children 1 month to 12 years with severe dehydration due to acute diarrhea

• Registration Number: CTRI/2015/01/005481
• Lead Sponsor: The Director

Brief Summary

Eligible children will be randomly assigned to receive either RL or NS. Intravenous fluid therapy will be instituted according to WHO acute diarrheal illness management guidelines (PLAN C). Children 1 month to 1 year will receive fluid correction over six hours (first 30ml/kg over 1hour, followed by 70ml/kg over 5 hours) and children more than 1 year old will receive correction over threehours (first 30ml/kg over 30 minutes, followed by 70ml/kg over 2 hours 30 minutes). They will be monitored continuously for vital signs and will be reassessed at end of 100 mL/kg infusion for clinical signs of dehydration. If any child will be found to be insevere dehydration at the end of the first correction, intravenous rehydration (100 mL/kg) will be repeated. If they will be found to have no features of severe dehydration, further management will be based on the existing WHO guidelines for treatment of some dehydration (PLAN B) and no dehydration (PLAN A). Before and At the end of 6 hours blood gas, serum electrolytes, blood urea and creatinine will be measured. Clinical features, lab reports, volume of fluid needed to correct severe dehydration will be noted.

The trial had to be stopped after an interim analysis by the independent data monitoring committee indicated the futility of continuing the study further with respect to primary endpoint.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-02
• Last Update Posted: 2020-08-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

• 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 −3 (less than70%) (Severe wasting)and or Height-for-age: SD-score less than −3 (less than 85%) (Severe stunting).
• Known systemic disease (cardiac, endocrine, neurologic, chronic renal failure) 5.
• Lethal malformations 6.
• Children who have already received RL or NS during this episode.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correction of severe dehydration in children with acute watery diarrhea, as measured by clinical signs of dehydration and improvement in pH	at end of 6 hours.

Secondary Outcome Measures

Name	Time	Method
•The changes in the serum electrolytes -sodium, potassium, chloride, bicarbonate, base-deficit and anion-gap	at end of 6 hours
•Time taken to start oral feeding	at end of dehydration correction (approximately 6 hours)
•The amount of fluid required to correct severe dehydration excluding first cycle of correction	at end of dehydration correction (approximately 12 hours)
•Length of hospital stay	Till discharge from hospital (approximately 5 days)

Trial Locations

Locations (1)

Department of Pediatrics; 🇮🇳 Pondicherry, PONDICHERRY, India

Department of Pediatrics

🇮🇳Pondicherry, PONDICHERRY, India

Dr Gayathri Bhuvaneswaran Kartha

Principal investigator

8870069729

oracleundefied@gmail.com