Comparing the Diagnostic Accuracy of Clinical Dehydration Scales Among Small Children

• Conditions: Dehydration

• Registration Number: NCT02249845
• Lead Sponsor: Medical University of Warsaw

Brief Summary

The assessment of clinical dehydration scales diagnostic accuracy (CDS scale, WHO scale, Gorelick scale) among small children.

Detailed Description

The eligible patient admitted to the hospital with acute diarrhea, after given written consent for participation in the study by the child's parents, will be clinically assessed. Dehydration syndromes noted by physician will be recorded in special form (in attachment). Than, the child will be weighted on a standard scale.

The next body mass evaluation will take place, when patient's clinical condition will by classified as good by the attending physician and the child will be at least 24 hours after finishing intravenous or probe rehydration therapy.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2014-09-23
• Study First Posted: 2014-09-26
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-15
• Last Update Posted: 2016-01-18
• Primary Completion: 2016-06
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• age: 1 - 36 months for CDS scale; 1 month - 5 years old for WHO scale and Gorelick scale
• hospitalisation caused by acute diarrhea (acute diarrhea -increase in the frequency of evacuations ≥ 3 in 24 hours; with or without fever or vomiting)
• duration of symptoms under 5 days
• parents' written consent for child's participation in the study

Exclusion Criteria

• Dehydration caused by other mechanisms than acute diarrhea, for example dehydration caused by:

  • acidosis
  • kidney failure
  • heart failure
  • chronic liver disease
  • respiratory failure
  • condition after surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
WHO scale evaluation	all necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)	sensitivity, specificity, positive and negative likelihood ratios for WHO scale for dehydration \<5%, 5-10%, \>10%
CDS scale evaluation	all necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)	sensitivity, specificity, positive and negative likelihood ratios for CDS scale for dehydration \<3%, 3-6%, \>6%
Gorelick scale evaluation	when all data will be collectedall necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)	sensitivity, specificity, positive and negative likelihood ratios for Gorelick scale for dehydration ≥5%, ≥10%

Trial Locations

Locations (1)

Department of Pediatrics, Medical University of Warsaw; 🇵🇱 Warsaw, Poland