DehydrationNCT03021109
Assessment of Volume Status by Bedside Ultrasound in Children With Acute Gastroenteritis
A study testing Measurement of inferior vena cava diameters with ultrasound in people with Dehydration and Acute Gastroenteritis, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study is assessment of volume status by bedside ultrasound in children with acute gastroenteritis Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Dehydration, Acute Gastroenteritis
- What is being tested?
- Measurement of inferior vena cava diameters with ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2016to 1 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients between 6 months and 18 years of age who presented to the Emergency Department with gastroenteritis
Who cannot join
- congenital heart disease
- chronic liver disease
- chronic renal disease
- patients or parents who doesn't want to enroll the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli Derince Training and Research Hospital
Kocaeli, Izmit, 41900
About this study
Official title: Assessment of Volume Status by Measurement of Caval Index by Bedside Ultrasound in Children With Acute Gastroenteritis
The purpose of the study is assessment of volume status by bedside ultrasound in children with acute gastroenteritis
Read the 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.
- Conditions
- Dehydration, Acute Gastroenteritis
- Being tested
- Measurement of inferior vena cava diameters with ultrasound
- Keywords
- ultrasound, pediatrics, gastroenteritis
- Medical subject headings
- Dehydration, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of inferior vena cava diameters with ultrasoundDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Inferior vena cava diameteres | Experimental | Measurement of inferior vena cava diameters with ultrasound Receives: Device: Measurement of inferior vena cava diameters with ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation of caval index with the amount of fluid loss in pediatric patients with acute gastroenteritis
Measured: 1 week
Secondary outcomes (1)
The correlation between physical examination findings and the amount of fluid loss in pediatric dehydration
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ASIM ENES ÖZBEK, Derince Training and Research Hospital
- Investigators
- Asım E. Özbek, Specialist, Principal investigator, Kocaeli Derince Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021109
- Sponsor's protocol ID
- 2016/278
- Status last verified
- Oct 2017
- First submitted
- 12 Jan 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 22136388Liebelt 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.
PubMed 9818241Steiner MJ, DeWalt DA, Byerley JS. Is this child dehydrated? JAMA. 2004 Jun 9;291(22):2746-54. doi: 10.1001/jama.291.22.2746.
PubMed 15187057McConnochie 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.
PubMed 10591299Haciomeroglu 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.
PubMed 17371335
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Volume Status by Measurement of Caval Index by Bedside Ultrasound in Children With Acute Gastroenteritis
- ClinicalTrials.gov ID
- NCT03021109
- Acronym / sponsor ID
- 2016/278
- Conditions
- Dehydration, Acute Gastroenteritis
- Keywords
- ultrasound, pediatrics, gastroenteritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inferior vena cava diameteres | Experimental | Device: Measurement of inferior vena cava diameters with ultrasoundMeasurement of inferior vena cava diameters with ultrasound |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients between 6 months and 18 years of age who presented to the Emergency Department with gastroenteritis
Key exclusion criteria (4 listed)
- congenital heart disease
- chronic liver disease
- chronic renal disease
- patients or parents who doesn't want to enroll 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of inferior vena cava diameters with ultrasoundThe 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 | Device | Inferior vena cava diameteres |
Primary outcome
The correlation of caval index with the amount of fluid loss in pediatric patients with acute gastroenteritis
Time frame: 1 week
1 secondary outcome
The correlation between physical examination findings and the amount of fluid loss in pediatric dehydration
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Background: PubMed 22136388van 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.
- Background: PubMed 9818241Liebelt 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.
- Background: PubMed 15187057Steiner MJ, DeWalt DA, Byerley JS. Is this child dehydrated? JAMA. 2004 Jun 9;291(22):2746-54. doi: 10.1001/jama.291.22.2746.
- Background: PubMed 10591299McConnochie 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.
- Background: PubMed 17371335Haciomeroglu 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Asım E. Özbek, Specialist principal investigator
Kocaeli Derince Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of inferior vena cava diameters with ultrasound in people with Dehydration and Acute Gastroenteritis, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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 17 Oct 2017. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The correlation of caval index with the amount of fluid loss in pediatric patients with acute gastroenteritis (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03021109, which also lists 5 linked publications.
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 17 Oct 2017.