Slow Versus Rapid Rehydration of Severely Malnourished Children

NCT02216708 | Completed Phase 2 DMC

• 1 other identifier: PR-11004
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diarrhea

Keywords

Severe malnutrition; severe dehydration; cholera

Outcome Measures

Primary Outcomes (2)

• Incidence of over- hydration

  7 days

• Proportion of patient with ORS failure/ requirement of unscheduled IV therapy

  7 days

Secondary Outcomes (1)

• Proportion of patient with acidosis and increased serum creatinine after 24 hours

  7 days

Study Arms (2)

intravenous fluid for rehydration rapidly over 6 hours

EXPERIMENTAL

intravenous fluid for rehydration rapidly over 6 hours

Other: Rapid dehydration

receive slow rehydration recommended by WHO (12 hours)

EXPERIMENTAL

receive intravenous fluid followed by ORS (slow rehydration recommended by WHO) over 12 hours

Other: Slow rehydration

Interventions

Rapid dehydration OTHER

intravenous fluid for rehydration rapidly over 6 hours

Slow rehydration OTHER

receive slow rehydration recommended by WHO (12 hours)

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

icddr,b Dhaka Hospital

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Diarrhea; Malnutrition; Dehydration; Cholera

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Pathologic Processes; Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: August 15, 2014
• Study Start: May 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 21, 2014

Record last verified: 2011-03

Locations

BA (1)