Slow Versus Rapid Rehydration of Severely Malnourished Children

Comparison of Rapid and Slow Rehydration of Severely Malnourished Children Suffering From Dehydrating Diarrhoea and Impact on Renal Function and Subsequent Growth of Children

The recommendation for correction of dehydration of severely malnourished children with diarrhoea includes oral rehydration and if parenteral rehydration is necessary (for example, in severe dehydration) to infuse intravenous fluids very slowly due to the concern of heart failure. There is not enough evidence to convince some of the physicians dealing with severely malnourished children with dehydrating diarrhoea (for example, cholera) that rapid rehydration per se is associated with increased incidence of over hydration and heart failure. And whether this approach is applicable in the management of severely malnourished children with severe cholera, which usually require rapid correction of water and electrolyte deficits for prevention of deaths due to hypovolaemic shock and other complications, has not been studied carefully. Recently, we have demonstrated that rapid intravenous rehydration (within 4 to 6 hours) of severely malnourished children with dehydrating cholera replacing appropriate amount of fluid was found to be safe. We feel that rapid rehydration would help in improving the renal function, acidosis and thus improve appetite and reduce ORS failure subsequently. Since our study was uncontrolled, so we have planned a randomised controlled study with adequate sample of 250 participants; 125 will be rehydrated slowly (over 10 to 12 hours) following WHO guideline and 125 patients will be rehydrated with intravenous fluid over 6 hours. Children of either gender, age 6 to 60 months, severely malnourished (Wt for length <-3 Z score of WHO growth chart or with nutritional oedema) with a history of watery of <24 hours with signs severe dehydration attending the ICDDRB Dhaka hospital will be asked to participate in this study. After the parents'/Legal guardian's consent, the children will be transferred to the study ward and will be treated according to the protocol. All children will receive similar treatment except the mode of rehydration, different for the two groups. The children will be closely monitored throughout the study period. The primary outcomes incidence of over hydration and ORS failure and secondary outcomes improvement of renal function and improvement of appetite measured by the food intake will be compared between the groups.

Study Overview

• Status: Completed
• Conditions: Diarrhea
• Intervention / Treatment: Other: Rapid dehydration; Other: Slow rehydration

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • icddr,b Dhaka Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. History of acute watery diarrhoea of <24 hours.
2. Either sex.
3. Severe dehydration according to WHO guidelines
4. Wt for length/wt for age < -3 SD of WHO growth standard with or without oedema.(malnutrition)
5. Consent given by the parents or legal guardian

Exclusion Criteria:

1. Bloody diarrhoea.
2. Severe infection (e.g. severe pneumonia, clinical sepsis, septic shock, meningitis).
3. Those who received antibiotics/antimicrobial for the current illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intravenous fluid for rehydration rapidly over 6 hours	Other: Rapid dehydration
Experimental: receive slow rehydration recommended by WHO (12 hours); receive intravenous fluid followed by ORS (slow rehydration recommended by WHO) over 12 hours	Other: Slow rehydration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of over- hydration	7 days
Proportion of patient with ORS failure/ requirement of unscheduled IV therapy	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patient with acidosis and increased serum creatinine after 24 hours	7 days

Collaborators and Investigators

• Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: August 13, 2014
• First Submitted That Met QC Criteria: August 13, 2014
• First Posted (Estimate): August 15, 2014

Study Record Updates

• Last Update Posted (Estimate): August 21, 2014
• Last Update Submitted That Met QC Criteria: August 20, 2014
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Severe malnutrition; severe dehydration; cholera
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: PR-11004