Clinical trial NCT03021109: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration
Acute Gastroenteritis
Keywords: ultrasound
pediatrics
gastroenteritis
Lead sponsor: Derince Training and Research Hospital
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 190
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: The correlation of caval index with the amount of fluid loss in pediatric patients with acute gastroenteritis
timeFrame: 1 week
Secondary outcomes:
measure: The correlation between physical examination findings and the amount of fluid loss in pediatric dehydration
timeFrame: 1 week
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli Derince Training and Research Hospital
state: Izmit
Study officials:
affiliation: Kocaeli Derince Training and Research Hospital
name: Asım E. Özbek, Specialist
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.