DehydrationNCT00267644
Ultrasound of the Inferior Vena Cava (IVC) and Dehydration Status in Pediatric Emergency Patients
An observational study of Dehydration, run by Antonios Likourezos at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Sep 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 3 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
None listed.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dehydration
- Keywords
- Children, dehydration, Ultrasound
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hydrated patients | Group 1 (n=63) were pediatric patiens that wer hydrated. | |
| Dehydrated Group | Group 2 (n=13) were pediatric patients that were dehydrated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum IVC Diameter
Maximum Inferior Vena Cava diameter in mm
Measured: 10 minutes
Secondary outcomes (1)
Minimum IVC Diameter
Minimum Inferior Vena Cava Diameter in mm
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DehydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonios Likourezos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonios Likourezos, Maimonides Medical Center
- Investigators
- Hashibul Hannan, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267644
- Sponsor's protocol ID
- 05-09-VA03
- Status last verified
- Apr 2013
- First submitted
- 19 Dec 2005
- Last updated
- 3 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound of the Inferior Vena Cava (IVC) and Dehydration Status in Pediatric Emergency Patients
- ClinicalTrials.gov ID
- NCT00267644
- Acronym / sponsor ID
- 05-09-VA03
- Conditions
- Dehydration
- Keywords
- Children, dehydration, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Antonios LikourezosUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 21 Dec 2005 (estimated)
- Results
- Posted 3 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrated patients | – | –Group 1 (n=63) were pediatric patiens that wer hydrated. |
| Dehydrated Group | – | –Group 2 (n=13) were pediatric patients that were dehydrated. |
Who may qualify
- Ages
- 1 month to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximum IVC Diameter
Time frame: 10 minutes
Maximum Inferior Vena Cava diameter in mm
1 secondary outcome
Minimum IVC Diameter
Time frame: 10 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hashibul Hannan, MD principal investigator
Maimonides Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dehydration, run by Antonios Likourezos at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum IVC Diameter (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2013.