DiarrheaPhase 2NCT02216708
Slow Versus Rapid Rehydration of Severely Malnourished Children
A Phase 2 study testing Rapid dehydration and Slow rehydration in people with Diarrhea, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Diarrhea
- What is being tested?
- Rapid dehydration and Slow rehydration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteBangladesh
- Study dates
- May 2011to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Bloody diarrhoea.
- Severe infection (e.g. severe pneumonia, clinical sepsis, septic shock, meningitis).
- Those who received antibiotics/antimicrobial for the current illness
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Rapid dehydration, Slow rehydration
- Keywords
- Severe malnutrition, severe dehydration, cholera
- Medical subject headings
- Diarrhea, Malnutrition, Dehydration, Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid dehydrationOther
Slow rehydrationOther
| Study group | Role | What they receive |
|---|---|---|
| intravenous fluid for rehydration rapidly over 6 hours | Experimental | intravenous fluid for rehydration rapidly over 6 hours Receives: 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 Receives: Other: Slow rehydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of over- hydration
Measured: 7 days
Proportion of patient with ORS failure/ requirement of unscheduled IV therapy
Measured: 7 days
Secondary outcomes (1)
Proportion of patient with acidosis and increased serum creatinine after 24 hours
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startMay 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216708
- Sponsor's protocol ID
- PR-11004
- Status last verified
- Mar 2011
- First submitted
- 13 Aug 2014
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02216708
- Acronym / sponsor ID
- PR-11004
- Conditions
- Diarrhea
- Keywords
- Severe malnutrition, severe dehydration, cholera
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous fluid for rehydration rapidly over 6 hours | Experimental | Other: Rapid dehydrationintravenous fluid for rehydration rapidly over 6 hours |
| receive slow rehydration recommended by WHO (12 hours) | Experimental | Other: Slow rehydrationreceive intravenous fluid followed by ORS (slow rehydration recommended by WHO) over 12 hours |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Bloody diarrhoea.
- Severe infection (e.g. severe pneumonia, clinical sepsis, septic shock, meningitis).
- Those who received antibiotics/antimicrobial for the current illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid dehydration | Other | intravenous fluid for rehydration rapidly over 6 hours |
| Slow rehydration | Other | receive slow rehydration recommended by WHO (12 hours) |
Primary outcome
Incidence of over- hydration
Time frame: 7 days
Proportion of patient with ORS failure/ requirement of unscheduled IV therapy
Time frame: 7 days
1 secondary outcome
Proportion of patient with acidosis and increased serum creatinine after 24 hours
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rapid dehydration and Slow rehydration in people with Diarrhea, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of over- hydration (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2014.