Severe DehydrationDHAKANCT02007733
DeHydration: Assessing Kids Accurately
An observational study of Severe Dehydration, run by Rhode Island Hospital at 1 site in Bangladesh.
Trial summary
Diarrhea is the second leading cause of death in children worldwide, and accurately assessing dehydration status remains a crucial step in preventing morbidity and mortality from this disease. Read more about this study
- Who is it for?
- Ages 1 month to 60 months
- Conditions the study is for
- Severe Dehydration
- What is being tested?
- Serial Weights, IVC/Aorta Ultrasound and Clinical Assessment
- How many people
- 1,396 participants
- Where
- 1 siteBangladesh
- Study dates
- Feb 2014to Jun 2015
- Phase
- Observational
- 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 1 month to 60 months
- All sexes
- No healthy volunteers
- Child
Study population: Children under five with acute diarrhea observed in the rehydration ward of the Dhaka Hospital of ICDDR,B.
Who may be able to join
- Age 5 years (60 months) or younger
- History of diarrhoea (defined as 3 or more loose stools per day)
- Children observed in the rehydration ward
Who cannot join
- Chronic diarrhoea (greater than 2 week duration)
- Clear alternative diagnosis to gastroenteritis on presentation
- Previously enroled in this research study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Severe Dehydration in Children With Diarrhea in Bangladesh
Diarrhea is the second leading cause of death in children worldwide, and accurately assessing dehydration status remains a crucial step in preventing morbidity and mortality from this disease. While children with severe dehydration require immediate treatment with intravenous fluids, children with mild to moderate dehydration have a significant reduction in hospital length of stay and fewer adverse events when treated with relatively inexpensive oral rehydration solution (ORS). While several clinical scales have been developed for assessing dehydration in children, these scales have never been prospectively validated in a low-income country setting, where the vast majority of diarrhea morbidity and mortality occurs in children.
The investigators hypothesize that new clinical and ultrasound-based tools will improve the diagnosis of severe dehydration in children with diarrhea in low-income countries, reducing the morbidity and mortality that occurs as a result of under-diagnosis of severe dehydration as well as the adverse events and inappropriate utilization of scarce resources that occurs as a result of over-diagnosis of severe dehydration.
Read the detailed description
Background:
Children under five experience 1.7 billion episodes of diarrhea each year, resulting in 36 million cases of severe disease and 700,000 deaths, or 10% of all child deaths worldwide. As the severity of diarrheal disease can vary quite widely in children, accurately assessing dehydration status remains a crucial step in preventing morbidity and mortality. While children with severe dehydration require immediate treatment with intravenous fluids to prevent hemodynamic compromise, organ ischemia, and death, children with mild to moderate dehydration have a significant reduction in hospital length of stay and fewer adverse events when treated with relatively inexpensive oral rehydration solution (ORS). The World Health Organization (WHO), the US Centers for Disease Control and Prevention (CDC), and the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) recommend separating children with acute diarrhea into three groups to determine management based on the presence or absence of various clinical signs: no dehydration (<3%), some dehydration (3-9%), and severe dehydration (>9%). These authorities recommend treating children with some dehydration with ORS and limiting IV hydration to children with severe dehydration, in order to prevent the inappropriate utilization of scarce hospital resources and the adverse events associated with a more liberal use of IV hydration in children. However, no clinical prediction model for severe dehydration has ever been empirically derived and validated in a developing world setting, where the vast majority of diarrheal deaths occur in children each year.
Study Objectives:
As part of this study, the investigators will derive a new clinical prediction rule for severe dehydration in children with diarrhea in the developing world. In addition, the investigators will validate and assess the reliability of ultrasound of the inferior vena cava (IVC) for predicting severe dehydration in children with diarrhea. Finally, the investigators will compare the accuracy of each of these new diagnostic tools to that of the WHO scale, the current standard for assessing dehydration in most low-income countries.
Study Design:
The investigators will enroll a prospective cohort of children under five admitted with diarrhea and dehydration to the Dhaka Hospital of the International Center for Diarrheal Disease Research, Bangladesh (ICDDR,B). Research staff will identify eligible children on arrival and obtain informed consent from their guardian. Children will be weighed on arrival and assessed clinically for the presence or absence of signs of dehydration. A brief ultrasound of the IVC will also be performed. Children will then be rehydrated according to standard hospital protocols, with their weight checked regularly until they achieve a stable, post-hydration weight. Greater than 9% difference between admission weight and stable weight (or post-illness weight) will be considered the gold standard for severe dehydration, against which the investigators will determine the accuracy of our new clinical and ultrasound-based assessment tools.
Ethical Protection of Human Subjects:
Children enrolled are very unlikely to be exposed to any additional risks or discomforts, either mental or physical, as a result of participating in this study. Study procedures will include physical exam and ultrasound, neither of which will expose children to increased harm, and study procedures will not delay any immediately necessary care, such as IV fluids. All data collected will be kept strictly confidential in a password-protected database. In addition to obtaining ethical approval from the Lifespan Institutional Review Board (IRB), the investigators have also already obtained approval from the ICDDR,B Ethical Review Committee.
- Conditions
- Severe Dehydration
- Being tested
- Serial Weights, IVC/Aorta Ultrasound, Clinical Assessment
- Keywords
- Diarrhea, Dehydration, Children, Resuscitation, Clinical Prediction Rule, Low Income Country, Bangladesh
- Medical subject headings
- Dehydration, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial WeightsOther
We will collect serial weights on all children enrolled in this study.
IVC/Aorta UltrasoundOther
We will perform an ultrasound assessment of the IVC and Aorta size in each child enrolled.
Clinical AssessmentOther
We will perform a clinical assessment of dehydration status in each child enrolled in the study, as well as collect data on mid-upper arm circumference, length, symptoms and demographic information.
| Study group | Role | What they receive |
|---|---|---|
| Derivation Cohort | The derivation cohort includes patients enrolled in the first phase of the study, from February 2014 to June 2014. All children enrolled in this study will receive the same interventions, which include collection of regular weights to establish percent weight change with rehydration, clinical assessment of dehydration status, and ultrasound of the IVC and aorta. Receives: Other: Serial Weights; Other: IVC/Aorta Ultrasound; Other: Clinical Assessment | |
| Validation Cohort | The validation cohort includes patients enrolled in the second phase of the study, from March 2015 to May 2015. All children enrolled in this study will receive the same interventions, which include collection of regular weights to establish percent weight change with rehydration, clinical assessment of dehydration status, and ultrasound of the IVC and aorta. Receives: Other: Serial Weights; Other: Clinical Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Receiver-Operator Characteristic (ROC) curve for predictors of severe diarrheal disease
We will follow all enrolled children for up to a maximum of 2 weeks to assess the percent change between initial dehydrated weight and stable rehydration weight or post-illness weight. Greater than 9% weight change or death prior to achieving stable weight will be our criterion standard for severe disease. We will then determine the area under the Receiver-Operator Characteristic (ROC) curves for our newly derived clinical scale (DHAKA scale); for ultrasound of the IVC to Aorta ratio; and for the WHO scale as predictors of severe diarrheal disease in children enrolled in our study.
Measured: 2 weeks
Secondary outcomes (1)
Area under the receiver operating curve for predictors of some dehydration
We will follow all enrolled children for up to a maximum of 2 weeks to assess the percent change between initial dehydrated weight and stable rehydration weight or post-illness weight. 3-9% weight change between arrival and stable weight or post-illness weight will be our criterion standard for some dehydration. We will then determine the area under the Receiver-Operator Characteristic (ROC) curves for our newly derived clinical scale (DHAKA scale); for ultrasound of the IVC to Aorta ratio; and for the WHO scale as predictors of some dehydration in children enrolled in our study.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Severe DehydrationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,396 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Sponsor
- Investigators
- Adam C. Levine, MD, MPH, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007733
- Sponsor's protocol ID
- 470125
- Other IDs
- 1K01TW009208-01A1
- Acronym
- DHAKA
- Status last verified
- Oct 2015
- First submitted
- 25 Nov 2013
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Levine AC, Glavis-Bloom J, Modi P, Nasrin S, Rege S, Chu C, Schmid CH, Alam NH. Empirically Derived Dehydration Scoring and Decision Tree Models for Children With Diarrhea: Assessment and Internal Validation in a Prospective Cohort Study in Dhaka, Bangladesh. Glob Health Sci Pract. 2015 Aug 18;3(3):405-18. doi: 10.9745/GHSP-D-15-00097.
PubMed 26374802Levine AC, Glavis-Bloom J, Modi P, Nasrin S, Atika B, Rege S, Robertson S, Schmid CH, Alam NH. External validation of the DHAKA score and comparison with the current IMCI algorithm for the assessment of dehydration in children with diarrhoea: a prospective cohort study. Lancet Glob Health. 2016 Oct;4(10):e744-51. doi: 10.1016/S2214-109X(16)30150-4. Epub 2016 Aug 23.
PubMed 27567350Modi P, Nasrin S, Hawes M, Glavis-Bloom J, Alam NH, Hossain MI, Levine AC. Midupper Arm Circumference Outperforms Weight-Based Measures of Nutritional Status in Children with Diarrhea. J Nutr. 2015 Jul;145(7):1582-7. doi: 10.3945/jn.114.209718. Epub 2015 May 13.
PubMed 25972523
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Severe Dehydration in Children With Diarrhea in Bangladesh
- ClinicalTrials.gov ID
- NCT02007733
- Acronym / sponsor ID
- DHAKA / 470125
- Conditions
- Severe Dehydration
- Keywords
- Diarrhea, Dehydration, Children, Resuscitation, Clinical Prediction Rule, Low Income Country, Bangladesh
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,396 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- Feb 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Dec 2013 (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.
Diarrhea is the second leading cause of death in children worldwide, and accurately assessing dehydration status remains a crucial step in preventing morbidity and mortality from this disease. While children with severe dehydration require immediate treatment with intravenous fluids, children with mild to moderate dehydration have a significant reduction in hospital length of stay and fewer adverse events when treated with relatively inexpensive oral rehydration solution (ORS). While several clinical scales have been developed for assessing dehydration in children, these scales have never been prospectively validated in a low-income country setting, where the vast majority of diarrhea morbidity and mortality occurs in children.
The investigators hypothesize that new clinical and ultrasound-based tools will improve the diagnosis of severe dehydration in children with diarrhea in low-income countries, reducing the morbidity and mortality that occurs as a result of under-diagnosis of severe dehydration as well as the adverse events and inappropriate utilization of scarce resources that occurs as a result of over-diagnosis of severe dehydration.
Detailed description
Background:
Children under five experience 1.7 billion episodes of diarrhea each year, resulting in 36 million cases of severe disease and 700,000 deaths, or 10% of all child deaths worldwide. As the severity of diarrheal disease can vary quite widely in children, accurately assessing dehydration status remains a crucial step in preventing morbidity and mortality. While children with severe dehydration require immediate treatment with intravenous fluids to prevent hemodynamic compromise, organ ischemia, and death, children with mild to moderate dehydration have a significant reduction in hospital length of stay and fewer adverse events when treated with relatively inexpensive oral rehydration solution (ORS). The World Health Organization (WHO), the US Centers for Disease Control and Prevention (CDC), and the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) recommend separating children with acute diarrhea into three groups to determine management based on the presence or absence of various clinical signs: no dehydration (<3%), some dehydration (3-9%), and severe dehydration (>9%). These authorities recommend treating children with some dehydration with ORS and limiting IV hydration to children with severe dehydration, in order to prevent the inappropriate utilization of scarce hospital resources and the adverse events associated with a more liberal use of IV hydration in children. However, no clinical prediction model for severe dehydration has ever been empirically derived and validated in a developing world setting, where the vast majority of diarrheal deaths occur in children each year.
Study Objectives:
As part of this study, the investigators will derive a new clinical prediction rule for severe dehydration in children with diarrhea in the developing world. In addition, the investigators will validate and assess the reliability of ultrasound of the inferior vena cava (IVC) for predicting severe dehydration in children with diarrhea. Finally, the investigators will compare the accuracy of each of these new diagnostic tools to that of the WHO scale, the current standard for assessing dehydration in most low-income countries.
Study Design:
The investigators will enroll a prospective cohort of children under five admitted with diarrhea and dehydration to the Dhaka Hospital of the International Center for Diarrheal Disease Research, Bangladesh (ICDDR,B). Research staff will identify eligible children on arrival and obtain informed consent from their guardian. Children will be weighed on arrival and assessed clinically for the presence or absence of signs of dehydration. A brief ultrasound of the IVC will also be performed. Children will then be rehydrated according to standard hospital protocols, with their weight checked regularly until they achieve a stable, post-hydration weight. Greater than 9% difference between admission weight and stable weight (or post-illness weight) will be considered the gold standard for severe dehydration, against which the investigators will determine the accuracy of our new clinical and ultrasound-based assessment tools.
Ethical Protection of Human Subjects:
Children enrolled are very unlikely to be exposed to any additional risks or discomforts, either mental or physical, as a result of participating in this study. Study procedures will include physical exam and ultrasound, neither of which will expose children to increased harm, and study procedures will not delay any immediately necessary care, such as IV fluids. All data collected will be kept strictly confidential in a password-protected database. In addition to obtaining ethical approval from the Lifespan Institutional Review Board (IRB), the investigators have also already obtained approval from the ICDDR,B Ethical Review Committee.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Derivation Cohort | – | Other: Serial Weights, Other: IVC/Aorta Ultrasound, Other: Clinical AssessmentThe derivation cohort includes patients enrolled in the first phase of the study, from February 2014 to June 2014. All children enrolled in this study will receive the same interventions, which include collection of regular weights to establish percent weight change with rehydration, clinical assessment of dehydration status, and ultrasound of the IVC and aorta. |
| Validation Cohort | – | Other: Serial Weights, Other: Clinical AssessmentThe validation cohort includes patients enrolled in the second phase of the study, from March 2015 to May 2015. All children enrolled in this study will receive the same interventions, which include collection of regular weights to establish percent weight change with rehydration, clinical assessment of dehydration status, and ultrasound of the IVC and aorta. |
Who may qualify
- Ages
- 1 month to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under five with acute diarrhea observed in the rehydration ward of the Dhaka Hospital of ICDDR,B.
Key inclusion criteria (3 listed)
- Age 5 years (60 months) or younger
- History of diarrhoea (defined as 3 or more loose stools per day)
- Children observed in the rehydration ward
Key exclusion criteria (3 listed)
- Chronic diarrhoea (greater than 2 week duration)
- Clear alternative diagnosis to gastroenteritis on presentation
- Previously enroled in this research study
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 |
|---|---|---|
| Serial WeightsWe will collect serial weights on all children enrolled in this study. | Other | Derivation Cohort, Validation Cohort |
| IVC/Aorta UltrasoundWe will perform an ultrasound assessment of the IVC and Aorta size in each child enrolled. | Other | Derivation Cohort |
| Clinical AssessmentWe will perform a clinical assessment of dehydration status in each child enrolled in the study, as well as collect data on mid-upper arm circumference, length, symptoms and demographic information. | Other | Derivation Cohort, Validation Cohort |
Primary outcome
Area under the Receiver-Operator Characteristic (ROC) curve for predictors of severe diarrheal disease
Time frame: 2 weeks
We will follow all enrolled children for up to a maximum of 2 weeks to assess the percent change between initial dehydrated weight and stable rehydration weight or post-illness weight. Greater than 9% weight change or death prior to achieving stable weight will be our criterion standard for severe disease. We will then determine the area under the Receiver-Operator Characteristic (ROC) curves for our newly derived clinical scale (DHAKA scale); for ultrasound of the IVC to Aorta ratio; and for the WHO scale as predictors of severe diarrheal disease in children enrolled in our study.
1 secondary outcome
Area under the receiver operating curve for predictors of some dehydration
Time frame: 2 weeks
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 23 Feb 2023.
- Results publication: PubMed 26374802Levine AC, Glavis-Bloom J, Modi P, Nasrin S, Rege S, Chu C, Schmid CH, Alam NH. Empirically Derived Dehydration Scoring and Decision Tree Models for Children With Diarrhea: Assessment and Internal Validation in a Prospective Cohort Study in Dhaka, Bangladesh. Glob Health Sci Pract. 2015 Aug 18;3(3):405-18. doi: 10.9745/GHSP-D-15-00097.
- Results publication: PubMed 27567350Levine AC, Glavis-Bloom J, Modi P, Nasrin S, Atika B, Rege S, Robertson S, Schmid CH, Alam NH. External validation of the DHAKA score and comparison with the current IMCI algorithm for the assessment of dehydration in children with diarrhoea: a prospective cohort study. Lancet Glob Health. 2016 Oct;4(10):e744-51. doi: 10.1016/S2214-109X(16)30150-4. Epub 2016 Aug 23.
- Derived from this study: PubMed 25972523Modi P, Nasrin S, Hawes M, Glavis-Bloom J, Alam NH, Hossain MI, Levine AC. Midupper Arm Circumference Outperforms Weight-Based Measures of Nutritional Status in Children with Diarrhea. J Nutr. 2015 Jul;145(7):1582-7. doi: 10.3945/jn.114.209718. Epub 2015 May 13.
- Principal Investigator WebsiteLink provided by the sponsor.
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Not yet recruiting
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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.
Adam C. Levine, MD, MPH principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Dehydration, run by Rhode Island Hospital 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 3 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 23 Feb 2023. 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.
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?
Area under the Receiver-Operator Characteristic (ROC) curve for predictors of severe diarrheal disease (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02007733, which also lists 3 linked publications.
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 23 Feb 2023.