Assessment of Volume Status by Bedside Ultrasound in Children With Acute Gastroenteritis
Primary Purpose
Dehydration, Acute Gastroenteritis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Measurement of inferior vena cava diameters with ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Dehydration focused on measuring ultrasound, pediatrics, gastroenteritis
Eligibility Criteria
Inclusion Criteria:
- Patients between 6 months and 18 years of age who presented to the Emergency Department with gastroenteritis
Exclusion Criteria:
- congenital heart disease
- chronic liver disease
- chronic renal disease
- patients or parents who doesn't want to enroll the study
Sites / Locations
- Kocaeli Derince Training and Research Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Inferior vena cava diameteres
Arm Description
Measurement of inferior vena cava diameters with ultrasound
Outcomes
Primary Outcome Measures
The correlation of caval index with the amount of fluid loss in pediatric patients with acute gastroenteritis
Secondary Outcome Measures
The correlation between physical examination findings and the amount of fluid loss in pediatric dehydration
Full Information
NCT ID
NCT03021109
First Posted
January 12, 2017
Last Updated
October 14, 2017
Sponsor
Derince Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03021109
Brief Title
Assessment of Volume Status by Bedside Ultrasound in Children With Acute Gastroenteritis
Official Title
Assessment of Volume Status by Measurement of Caval Index by Bedside Ultrasound in Children With Acute Gastroenteritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
October 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Derince Training and Research Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is assessment of volume status by bedside ultrasound in children with acute gastroenteritis
Detailed Description
The research will be conducted of emergency medicine department in the Derince Training and Research Hospital. Patients referred to acute gastroenteritis will be included to the study. After initial evaluation, the clinician will inform the principal investigator about the patient. The principal investigator will record the patient's demographic data, contact information, vital signs, history, physical examination findings, and weight. Than expirium and inspirium diameters of vena cava inferior will be measured with the bedside ultrasound and caval index will be calculated. An investigator who have had an ultrasound certification by Emergency Medicine Association of Turkey for six years will make the measurements. After 1 week the patient will called up for re-evaluation. Applicants' weights will be measured again with the same weighing machine. The differences between initial and after one week weight measurement will be accepted as the gold standard method for volume loss. The weight loss of the patient, the dehydration findings detected on physical examination and the caval index will be compared.
Data will be collected on predesigned data sheets, by an investigator and subsequently will be entered into a spreadsheet (Excel 2007; Microsoft, Redmond, WA). All recorded data will be checked by an another investigator to identify possible errors. Results will be submitted at least every two months.
Linear regression will be performed with dehydration as the dependent variable and the caval index as the independent variable.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration, Acute Gastroenteritis
Keywords
ultrasound, pediatrics, gastroenteritis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inferior vena cava diameteres
Arm Type
Experimental
Arm Description
Measurement of inferior vena cava diameters with ultrasound
Intervention Type
Device
Intervention Name(s)
Measurement of inferior vena cava diameters with ultrasound
Intervention Description
The patient is placed in the supine position. Curvilinear probe is used. Subxiphoid view is obtained. The IVC is visualized in the longitudinal plane as it enters the right atrium. The diameter of the IVC for calculation of the caval index is measured 2 cm from where it enters the right atrium
Primary Outcome Measure Information:
Title
The correlation of caval index with the amount of fluid loss in pediatric patients with acute gastroenteritis
Time Frame
1 week
Secondary Outcome Measure Information:
Title
The correlation between physical examination findings and the amount of fluid loss in pediatric dehydration
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients between 6 months and 18 years of age who presented to the Emergency Department with gastroenteritis
Exclusion Criteria:
congenital heart disease
chronic liver disease
chronic renal disease
patients or parents who doesn't want to enroll the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asım E. Özbek, Specialist
Organizational Affiliation
Kocaeli Derince Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli Derince Training and Research Hospital
City
Kocaeli
State/Province
Izmit
ZIP/Postal Code
41900
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22136388
Citation
van den Berg J, Berger MY. Guidelines on acute gastroenteritis in children: a critical appraisal of their quality and applicability in primary care. BMC Fam Pract. 2011 Dec 2;12:134. doi: 10.1186/1471-2296-12-134.
Results Reference
background
PubMed Identifier
9818241
Citation
Liebelt EL. Clinical and laboratory evaluation and management of children with vomiting, diarrhea, and dehydration. Curr Opin Pediatr. 1998 Oct;10(5):461-9. doi: 10.1097/00008480-199810000-00002.
Results Reference
background
PubMed Identifier
15187057
Citation
Steiner MJ, DeWalt DA, Byerley JS. Is this child dehydrated? JAMA. 2004 Jun 9;291(22):2746-54. doi: 10.1001/jama.291.22.2746.
Results Reference
background
PubMed Identifier
10591299
Citation
McConnochie KM, Conners GP, Lu E, Wilson C. How commonly are children hospitalized for dehydration eligible for care in alternative settings? Arch Pediatr Adolesc Med. 1999 Dec;153(12):1233-41. doi: 10.1001/archpedi.153.12.1233.
Results Reference
background
PubMed Identifier
17371335
Citation
Haciomeroglu P, Ozkaya O, Gunal N, Baysal K. Venous collapsibility index changes in children on dialysis. Nephrology (Carlton). 2007 Apr;12(2):135-9. doi: 10.1111/j.1440-1797.2006.00700.x.
Results Reference
background
Links:
URL
http://www.who.int/mediacentre/factsheets/fs330/en/
Description
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Assessment of Volume Status by Bedside Ultrasound in Children With Acute Gastroenteritis
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