Comparing the Diagnostic Accuracy of Clinical Dehydration Scales Among Small Children

Dehydration Clinical Trial

Official title:

Comparing the Diagnostic Accuracy of Clinical Dehydration Scales Among Small Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02249845
• Other study ID #: CDS
• Status: Recruiting
• Phase: N/A
• First received: September 15, 2014
• Last updated: January 15, 2016
• Start date: September 2014
• Est. completion date: August 2016

Study information

• Verified date: January 2016
• Source: Medical University of Warsaw
• Contact: Anna Falszewska, MD
• Phone: +48224523309
• Email: annafalszewska[@]gmail.com
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 5 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dehydration

Locations

Country	Name	City	State
Poland	Department of Pediatrics, Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CDS scale evaluation	sensitivity, specificity, positive and negative likelihood ratios for CDS scale for dehydration <3%, 3-6%, >6%	all necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)	No
Primary	WHO scale evaluation	sensitivity, specificity, positive and negative likelihood ratios for WHO scale for dehydration <5%, 5-10%, >10%	all necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)	No
Primary	Gorelick scale evaluation	sensitivity, specificity, positive and negative likelihood ratios for Gorelick scale for dehydration =5%, =10%	when all data will be collectedall necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)	No