- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03670394
Capillary Refill for Assessment of Dehydration
April 16, 2020 updated by: Dr. David Sheridan, Oregon Health and Science University
Capillary Refill to Detect Dehydration in Children
Capillary refill is used clinically to assess multiple things in children.
This is a prospective observational study of the correlation between capillary refill time and degree of dehydration in children seen in a pediatric ED.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
All patient presenting to the pediatric ER at OHSU less than 10 years are eligible to be enrolled if being seen for a condition putting them at risk for dehydration including emesis, diarrhea, etc. Children will have their capillary refill time measured and then sent home with a digital scale to track their weight.
This will serve as the standard for calculating percent dehydration.
When a patient has reached a stable weight at 1 week we will assume this is their healthy weight.
There is no intervention in the study.
Study Type
Observational
Enrollment (Actual)
178
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
-
-
Oregon
-
Portland, Oregon, United States, 97239
- OHSU
-
-
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
10 months to 8 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients presenting to the pediatric ER at OHSu.
Description
Inclusion Criteria:
- All children with chief complaint of diarrhea, emesis, nausea, abdominal pain
Exclusion Criteria:
- Any child with chronic cardiac or pulm disease, raynauds syndrome, bilateral upper extremity trauma, previously enrolled in the study, already received IVF in the previous 48hrs, surgery within 1week, osteogenesis imperfecta.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Capillary Refill time
Time Frame: 1 week
|
Assessing correlation of the refill time and percent dehydration
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David Sheridan, MD MR, Oregon Health and Science University
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 (Actual)
September 10, 2018
Primary Completion (Actual)
April 1, 2020
Study Completion (Actual)
April 1, 2020
Study Registration Dates
First Submitted
September 12, 2018
First Submitted That Met QC Criteria
September 12, 2018
First Posted (Actual)
September 13, 2018
Study Record Updates
Last Update Posted (Actual)
April 17, 2020
Last Update Submitted That Met QC Criteria
April 16, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dehydration Assessment
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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