DeHydration: Assessing Kids Accurately

Severe Dehydration Clinical Trial

— DHAKA  

Official title:

Assessment of Severe Dehydration in Children With Diarrhea in Bangladesh

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007733
• Other study ID #: 470125
• Secondary ID: 1K01TW009208-01A
• Status: Completed
• Start date: February 2014
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1396
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 60 Months

Eligibility

Inclusion Criteria:

1. Age 5 years (60 months) or younger

2. History of diarrhoea (defined as 3 or more loose stools per day)

3. Children observed in the rehydration ward

Exclusion Criteria:

1. Chronic diarrhoea (greater than 2 week duration)

2. Clear alternative diagnosis to gastroenteritis on presentation

3. Previously enroled in this research study

Related Conditions & MeSH terms

• Dehydration
• Severe Dehydration

Intervention

Other:
• Serial Weights
We will collect serial weights on all children enrolled in this study.
• IVC/Aorta Ultrasound
We will perform an ultrasound assessment of the IVC and Aorta size in each child enrolled.
• 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.

Locations

Country	Name	City	State
Bangladesh	Dhaka Hospital of ICDDR,B	Dhaka

Sponsors (3)

Lead Sponsor	Collaborator
Rhode Island Hospital	Fogarty International Center of the National Institute of Health, International Centre for Diarrhoeal Disease Research, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

References & Publications (2)

Levine 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 prospectiv — View Citation

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, Banglad — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sub-group analyses	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).	2 weeks
Primary	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.	2 weeks
Secondary	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.	2 weeks

External Links

•   Principal Investigator Website