Slow Versus Rapid Rehydration of Severely Malnourished Children
Primary Purpose
Diarrhea
Status
Completed
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Rapid dehydration
Slow rehydration
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea focused on measuring Severe malnutrition, severe dehydration, cholera
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Bloody diarrhoea.
- Severe infection (e.g. severe pneumonia, clinical sepsis, septic shock, meningitis).
- Those who received antibiotics/antimicrobial for the current illness
Sites / Locations
- icddr,b Dhaka Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
intravenous fluid for rehydration rapidly over 6 hours
receive slow rehydration recommended by WHO (12 hours)
Arm Description
intravenous fluid for rehydration rapidly over 6 hours
receive intravenous fluid followed by ORS (slow rehydration recommended by WHO) over 12 hours
Outcomes
Primary Outcome Measures
Incidence of over- hydration
Proportion of patient with ORS failure/ requirement of unscheduled IV therapy
Secondary Outcome Measures
Proportion of patient with acidosis and increased serum creatinine after 24 hours
Full Information
NCT ID
NCT02216708
First Posted
August 13, 2014
Last Updated
August 20, 2014
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
1. Study Identification
Unique Protocol Identification Number
NCT02216708
Brief Title
Slow Versus Rapid Rehydration of Severely Malnourished Children
Official Title
Comparison of Rapid and Slow Rehydration of Severely Malnourished Children Suffering From Dehydrating Diarrhoea and Impact on Renal Function and Subsequent Growth of Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
Severe malnutrition, severe dehydration, cholera
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intravenous fluid for rehydration rapidly over 6 hours
Arm Type
Experimental
Arm Description
intravenous fluid for rehydration rapidly over 6 hours
Arm Title
receive slow rehydration recommended by WHO (12 hours)
Arm Type
Experimental
Arm Description
receive intravenous fluid followed by ORS (slow rehydration recommended by WHO) over 12 hours
Intervention Type
Other
Intervention Name(s)
Rapid dehydration
Intervention Type
Other
Intervention Name(s)
Slow rehydration
Primary Outcome Measure Information:
Title
Incidence of over- hydration
Time Frame
7 days
Title
Proportion of patient with ORS failure/ requirement of unscheduled IV therapy
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Proportion of patient with acidosis and increased serum creatinine after 24 hours
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Bloody diarrhoea.
Severe infection (e.g. severe pneumonia, clinical sepsis, septic shock, meningitis).
Those who received antibiotics/antimicrobial for the current illness
Facility Information:
Facility Name
icddr,b Dhaka Hospital
City
Dhaka
Country
Bangladesh
12. IPD Sharing Statement
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Slow Versus Rapid Rehydration of Severely Malnourished Children
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