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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00267644
Enrollment
76
Registered
2005-12-21
Start date
2005-12-31
Completion date
2009-09-30
Last updated
2013-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehydration

Keywords

Children, dehydration, Ultrasound

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.

Detailed description

Ultrasound is considered a routine procedure in the ED. In MMC all ultrasound done by ED staff is documented, however patients are not billed for it. All the ultrasound images for this study will have to be approved by Dr. Marshall prior to inclusion into the study. For the purposes of this study, trans-abdominal ultrasonographic measurements of the Inferior Vena Cava (IVC) will be taken in patients suspected of being Dehydrated. The Triage Nurse will be the person who would identify acutely dehydrated patient. Once a potential candidate is identified The Attending physician in the pediatric ED will be notified. If a sonographer is available in the ED at the time and he/she is free/willing to perform the sonogram only then will the attending physician will notify and consent the patient. The first phase of the study will concentrate on establishing the correlation between collapsed IVC and level of dehydration. During the first part of the study, ultrasonography will be performed once prior to hydration. During this phase we will also perform sonograms on a control group. The Control Group will consist of children aged 1 month to 3 years age who we do not suspect of being dehydrated based on initial evaluation and presenting complaints. During the second phase of the study we will measure the change in IVC diameter with fluid resuscitation. During this time, additional ultrasonography will be performed after adequate fluid resuscitation. Return Visit: For the patient that qualify for a return visit for a weight check, upon arrival to the ED, will bypass registration and report to the triage nurse and identify themselves, where they will be weighed and then promptly sent home. Who needs a return visit? Any patient who is not admitted or does not have a recent weight available (at the PMD's office) prior to the onset of the current condition will qualify for a return visit. The patients who has a recent weight taken at the PMD's office will be requested to sign the hospitals standard consent for transfer of the data via fax from the PMD's office.

Interventions

None listed

Sponsors

Antonios Likourezos
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 3 Years
Healthy volunteers
Yes

Inclusion criteria

Any patient 1-month to 36 months of age presenting to the ED with a History or vomiting, Diarrhea or decreased PO intake in which the Attending physician is concerned about Dehydration (cases) and patients in the same age group who are not suspected of dehydration (controls). \-

Exclusion criteria

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. \-

Design outcomes

Primary

MeasureTime frameDescription
Maximum IVC Diameter10 minutesMaximum Inferior Vena Cava diameter in mm

Secondary

MeasureTime frameDescription
Minimum IVC Diameter10 minutesMinimum Inferior Vena Cava Diameter in mm

Countries

United States

Participant flow

Recruitment details

Patients were recruited from the Pediatric ED from

Pre-assignment details

NO patient was excluded from the trial

Participants by arm

ArmCount
Cases13
Controls63
Total76

Baseline characteristics

CharacteristicControlsTotalCases
Age, Categorical
<=18 years
63 Participants76 Participants13 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age Continuous1.2 years
STANDARD_DEVIATION 0.41
1.5 years
STANDARD_DEVIATION 0.83
1.6 years
STANDARD_DEVIATION 0.83
Region of Enrollment
United States
63 participants76 participants13 participants
Sex: Female, Male
Female
36 Participants40 Participants4 Participants
Sex: Female, Male
Male
27 Participants36 Participants9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 130 / 63
serious
Total, serious adverse events
0 / 130 / 63

Outcome results

Primary

Maximum IVC Diameter

Maximum Inferior Vena Cava diameter in mm

Time frame: 10 minutes

ArmMeasureValue (MEDIAN)
CasesMaximum IVC Diameter38 mm
ControlsMaximum IVC Diameter64 mm
Secondary

Minimum IVC Diameter

Minimum Inferior Vena Cava Diameter in mm

Time frame: 10 minutes

ArmMeasureValue (MEDIAN)
CasesMinimum IVC Diameter30 mm
ControlsMinimum IVC Diameter45 mm

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026