Clinical Trial: DeHydration: Assessing Kids Accurately
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Assessment of Severe Dehydration in Children With Diarrhea in Bangladesh
Brief 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. 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 Summary:
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 diar
Sponsor: Rhode Island Hospital
Current Primary Outcome: Area under the Receiver-Operator Characteristic (ROC) curve for predictors of severe diarrheal disease [ Time Frame: 2 weeks ]
Original Primary Outcome: Area under the Receiver-Operator Characteristic (ROC) curve for predictors of severe diarrheal disease [ Time Frame: 2 weeks ]
Current Secondary Outcome: Area under the receiver operating curve for predictors of some dehydration [ Time Frame: 2 weeks ]
Original Secondary Outcome:
Information By: Rhode Island Hospital
Dates:
Date Received: November 25, 2013
Date Started: February 2014
Date Completion: June 2015
Last Updated: May 4, 2015
Last Verified: June 2014