DeHydration: Assessing Kids Accurately
Condition: Severe Dehydration
MeSH terms: Dehydration
Study type: Observational

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 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.
    

Intervention name(s): Serial Weights; IVC/Aorta Ultrasound; Clinical Assessment
Intervention type(s): Other; Other; Other
Intervention description(s): We will collect serial weights on all children enrolled in this study.; We will perform an ultrasound assessment of the IVC and Aorta size in each child enrolled.; 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.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children under five with acute diarrhea observed in the rehydration ward of the Dhaka
        Hospital of ICDDR,B.
      
Keywords: Diarrhea; Dehydration; Children; Resuscitation; Clinical Prediction Rule; Low Income Country; Bangladesh