Comparing the Diagnostic Accuracy of Clinical Dehydration Scales Among Small Children

January 15, 2016 updated by: Piotr Dziechciarz, MD, Medical University of Warsaw
The assessment of clinical dehydration scales diagnostic accuracy (CDS scale, WHO scale, Gorelick scale) among small children.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 01-184
        • Recruiting
        • Department of Pediatrics, Medical University of Warsaw
        • Principal Investigator:
          • Anna Falszewska, MD
        • Sub-Investigator:
          • Małgorzata Piescik, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Small children with acute diarrhoea admitted to the pediatric ward.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
dehydration scales
children aged 1 - 36 months for CDS scale; 1 month - 5 years old for WHO scale and Gorelick scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CDS scale evaluation
Time Frame: 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%
all necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)
WHO scale evaluation
Time Frame: 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%
all necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)
Gorelick scale evaluation
Time Frame: 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%
when all data will be collectedall necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Principal Investigator: Anna Falszewska, MD, Medical University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

September 15, 2014

First Submitted That Met QC Criteria

September 23, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Estimate)

January 18, 2016

Last Update Submitted That Met QC Criteria

January 15, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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