Ultrasound of the Inferior Vena Cava (IVC) and Dehydration Status in Pediatric Emergency Patients

NCT00267644 | Completed Results DMC

• 1 other identifier: 05-09-VA03
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Although approximately 9% of patients presenting to a Pediatric Emergency Department (ED) are dehydrated, there is no reliable method to measure objectively the degree of intravascular dehydration. Respiratory changes in Inferior Vena Cava (IVC) diameter have been shown to predict volume status in adults. Previous research has demonstrated correlation between IVC diameter and volume status in children undergoing hemodialysis. Other studies have shown that IVC diameter in children can be sonographically measured rapidly and accurately by ED physicians. If we can establish that IVC diameter predicts volume status in dehydrated children, this tool could assist the ED physician in rapid diagnosis and prompt resuscitation without the need to wait for blood or urine tests. In this study we use the "dehydrated patient" as a model for hypovolemia, with the idea that the data could ultimately be used in the setting of any hypovolemic state. We aim to evaluate whether ultrasound of the pediatric IVC can be used to reliably assess volume status. Methods: This is a prospective cohort study. Pediatric ED patients ranging in age from 1 to 41 months were assessed by a Pediatric emergency physician and stratified as either clinically euvolemic or hypovolemic. After consent was obtained, one of three Emergency Medicine Residents performed trans-abdominal sonographic measurements of the IVC diameter. Measurements of the IVC diameter just caudal to the insertion of the hepatic veins were obtained in a longitudinal orientation.

Conditions

Dehydration

Keywords

Children, dehydration, Ultrasound

Outcome Measures

Primary Outcomes (1)

• Maximum IVC Diameter

  Maximum Inferior Vena Cava diameter in mm

  10 minutes

Secondary Outcomes (1)

• Minimum IVC Diameter

  10 minutes

Study Arms (2)

Hydrated patients

Group 1 (n=63) were pediatric patiens that wer hydrated.

Dehydrated Group

Group 2 (n=13) were pediatric patients that were dehydrated.

Eligibility Criteria

• Age: 1 Month - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Any ED patient 1-month to 41 months of age presenting to the ED with a History or vomiting, Diarrhea or decreased PO intake

You may not qualify if:

• a. Presentation to the ED is more than 5 days from onset of symptoms. b. Upon initial evaluation patient who are thought to need immediate resuscitation will be excluded for the study.

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Eitan Dickman, MD; Principal Investigator
• Organization: Maimonides Medical Center

edickman@maimonidesmed.org

718-283-6057

Study Officials

• Hashibul Hannan, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: December 19, 2005
• First Posted: December 21, 2005
• Study Start: December 1, 2005
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: July 3, 2013
• Results First Posted: July 3, 2013

Record last verified: 2013-04

Locations

US (1)