DehydrationNCT02249845
Comparing the Diagnostic Accuracy of Clinical Dehydration Scales Among Small Children
An observational study of Dehydration, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The assessment of clinical dehydration scales diagnostic accuracy (CDS scale, WHO scale, Gorelick scale) among small children. Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Dehydration
- How many people
- 108 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2014to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Small children with acute diarrhoea admitted to the pediatric ward.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Pediatrics, Medical University of Warsaw
Warsaw, 01-184
Anna Falszewska, MD
Małgorzata Piescik, MD
About this study
The assessment of clinical dehydration scales diagnostic accuracy (CDS scale, WHO scale, Gorelick scale) among small children.
Read the 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.
- Conditions
- Dehydration
- Keywords
- dehydration, children, gastroenteritis
- Medical subject headings
- Dehydration, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| dehydration scales | children aged 1 - 36 months for CDS scale; 1 month - 5 years old for WHO scale and Gorelick scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
CDS scale evaluation
sensitivity, specificity, positive and negative likelihood ratios for CDS scale for dehydration <3%, 3-6%, >6%
Measured: all necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)
WHO scale evaluation
sensitivity, specificity, positive and negative likelihood ratios for WHO scale for dehydration <5%, 5-10%, >10%
Measured: all necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)
Gorelick scale evaluation
sensitivity, specificity, positive and negative likelihood ratios for Gorelick scale for dehydration ≥5%, ≥10%
Measured: when all data will be collectedall necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Dziechciarz, MD, Medical University of Warsaw
- Investigators
- Anna Falszewska, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249845
- Sponsor's protocol ID
- CDS
- Status last verified
- Jan 2016
- First submitted
- 15 Sep 2014
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Diagnostic Accuracy of Clinical Dehydration Scales Among Small Children
- ClinicalTrials.gov ID
- NCT02249845
- Acronym / sponsor ID
- CDS
- Conditions
- Dehydration
- Keywords
- dehydration, children, gastroenteritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dehydration scales | – | –children aged 1 - 36 months for CDS scale; 1 month - 5 years old for WHO scale and Gorelick scale |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Small children with acute diarrhoea admitted to the pediatric ward.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Dehydration caused by other mechanisms than acute diarrhea, for example dehydration caused by:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%
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%
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%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Falszewska, MD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dehydration, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Falszewska, MD (+48224523309, annafalszewska@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CDS scale evaluation (time frame: all necessary data will be collected till patient's discharge day (ca. 5 days after admition to the hospital)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2016; AzTrials last refreshed its copy on 7 Nov 2026.