Assessment of Volume Status by Bedside Ultrasound in Children With Acute Gastroenteritis

Dehydration Clinical Trial

Official title:

Assessment of Volume Status by Measurement of Caval Index by Bedside Ultrasound in Children With Acute Gastroenteritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03021109
• Other study ID #: 2016/278
• Status: Completed
• Phase: N/A
• First received: January 12, 2017
• Last updated: October 14, 2017
• Start date: December 2016
• Est. completion date: October 1, 2017

Study information

• Verified date: October 2017
• Source: Derince Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is assessment of volume status by bedside ultrasound in children with acute gastroenteritis

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Dehydration
• Gastroenteritis

Intervention

Device:
• Measurement of inferior vena cava diameters with ultrasound
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

Locations

Country	Name	City	State
Turkey	Kocaeli Derince Training and Research Hospital	Kocaeli	Izmit

Sponsors (1)

Lead Sponsor	Collaborator
Derince Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Haciomeroglu P, Ozkaya O, Gunal N, Baysal K. Venous collapsibility index changes in children on dialysis. Nephrology (Carlton). 2007 Apr;12(2):135-9. — View 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. Review. — View 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. — View Citation

Steiner MJ, DeWalt DA, Byerley JS. Is this child dehydrated? JAMA. 2004 Jun 9;291(22):2746-54. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation of caval index with the amount of fluid loss in pediatric patients with acute gastroenteritis		1 week
Secondary	The correlation between physical examination findings and the amount of fluid loss in pediatric dehydration		1 week

External Links

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