DeHydration: Assessing Kids Accurately (DHAKA)
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|ClinicalTrials.gov Identifier: NCT02007733|
Recruitment Status : Unknown
Verified June 2014 by Rhode Island Hospital.
Recruitment status was: Active, not recruiting
First Posted : December 11, 2013
Last Update Posted : May 5, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Severe Dehydration||Other: Serial Weights Other: IVC/Aorta Ultrasound Other: Clinical Assessment||Not Applicable|
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1700 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Severe Dehydration in Children With Diarrhea in Bangladesh|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||June 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.
Other: Serial Weights
We will collect serial weights on all children enrolled in this study.
Other: IVC/Aorta Ultrasound
We will perform an ultrasound assessment of the IVC and Aorta size in each child enrolled.
Other: Clinical Assessment
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.
- 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.
- Area under the receiver operating curve for predictors of some dehydration [ 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. 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.
- Sub-group analyses [ Time Frame: 2 weeks ]We will perform subgroup analyses for all of our predictors of dehydration in children by age, nutrition status, and type of diarrhea (watery versus bloody).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007733
|Dhaka Hospital of ICDDR,B|
|Principal Investigator:||Adam C. Levine, MD, MPH||Brown University|