GastroenteritisNCT04463082
Non-invasive Assessment of the Current State of Hydration in Children by Ultrasound
A study testing Intravenous administration of fluids in people with Gastroenteritis and Diabetes Mellitus (Ketoacidosis), run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
Children with clinical signs of severe dehydration will be examined by ultrasound in a supine position during admission. Children aged between 1 and 15years will be divided into three weight groups: 10-20kg, 20-30kg, 30-50kg. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Gastroenteritis, Diabetes Mellitus (Ketoacidosis)
- What is being tested?
- Intravenous administration of fluids
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2020to 1 Oct 2021
- 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 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- previously healthy children
- history and clinical signs of dehydration (gastroenteritis, diabetic ketoacidosis)
Who cannot join
- congenital heart diseases
- intestinal obstruction
- any signs of abdominal hypertension
- any illnesses known to affect the volume status
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
About this study
Official title: Assessment of the Current State of Volume Status in Children by Ultrasound Measurement of Vena Cava Inferior and Vena Jugularis Interna Combined With Passive Leg Raise: a Pilot Study
Children with clinical signs of severe dehydration will be examined by ultrasound in a supine position during admission. Children aged between 1 and 15years will be divided into three weight groups: 10-20kg, 20-30kg, 30-50kg. Early after admission 1st measurement of diameters of vena cava inferior (VCImax, VCImin) during breathing cycles and diameters of both venae jugulares (VJI dx max, min, VJI sin max, min) before and after passive leg raise maneuver will be recorded. After a defined fluid infusion within 60 minutes, a second examination will be evaluated and compared with the first one. The investigators considered also echocardiography to measure CO changes however they wanted to make it as simple as it might be at emergency during the night shift without an experienced cardiologist.
Read the detailed description
Only children admitted to the hospital with clinically detectable dehydration (weight loss, dry skin, sunken eyes, no tears) will be evaluated. Weight, noninvasive blood pressure measurement, pulse rate will be recorded. Measurements would be performed with an ultrasound probe with a low frequency (2-5 MHz), a curved array transducer will be used. In the supine position, the ultrasound probe will be placed in the substernal area, in the longitudinal and transversal plane, 1 cm caudal to the confluence of the hepatic veins, and it will be operated in M-mode. The largest (VCImax) and smallest (VCImin) diameters will be measured and the collapsibility index will be calculated (according to the formula: VCImax - VCI min / VCI max x100). Immediately after this examination measurement of the right VJImax, min and the left VJImax, min will be measured again in the supine position, then after passive leg raise (lifting the lower limbs 45st. for at least 1minute ) VJImax, min. and left VJImax, min will be measured. The collapsibility index for right and left VJI would be calculated according to the formula: VJImax - VJI min / VJI max x100. After a defined fluid infusion (20ml/kg, but the maximum volume will be limited to 500ml, this means that over 25kg weight we would apply not more than 500ml) within 60 minutes. A control examination of VCI, right VJI, and left VJI will be evaluated the same way as first and compared with the previous one.
- Conditions
- Gastroenteritis, Diabetes Mellitus (Ketoacidosis)
- Being tested
- Intravenous administration of fluids
- Keywords
- children, dehydration, ultrasound, vena cava inferior, vena jugularis, passive leg raise
- Medical subject headings
- Gastroenteritis, Diabetes Mellitus, Ketosis, Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous administration of fluidsProcedure or surgery
Intravenous administration of fluids (20ml/kg, but the maximum volume will be limited up to 500ml) within 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Weight category 10-20kg | Experimental | Pediatric patients with a weight of 10-20kg will be enrolled in this arm. Receives: Procedure: Intravenous administration of fluids |
| Weight category 20-30kg | Experimental | Pediatric patients with a weight of 20-30kg will be enrolled in this arm. Receives: Procedure: Intravenous administration of fluids |
| Weight category 30-50kg | Experimental | Pediatric patients with a weight of 30-50kg will be enrolled in this arm. Receives: Procedure: Intravenous administration of fluids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vena cava inferior diameter pre- and post-hydration
Change in vena cava inferior diameter (in millimetres) will be measured before and after hydration.
Measured: 60 minutes
Change in vena jugularis interna diameter pre- and post-hydration (on the right side)
Change in vena jugularis interna diameter (in millimetres) will be measured before and after hydration (on the right side).
Measured: 60 minutes
Change in vena jugularis interna diameter pre- and post-hydration (on the left side)
Change in vena jugularis interna diameter (in millimetres) will be measured before and after hydration (on the left side).
Measured: 60 minutes
Change in collapsibility index pre- and post-hydration
Change in collapsibility index values (in per cent) will be measured before and after hydration.
Measured: 60 minutes
Secondary outcomes (1)
Correlation to body surface area
All obtained parameters from the other Outcome Measures will be correlated to the body surface area of the patient (measured in m2)
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Sep 2020
- Primary completion1 Sep 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GastroenteritisStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The pediatric patients will be divided into three groups, according to weight: 10-20kg, 20-30kg, 30-50kg.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ostrava
- Responsible party
- Sponsor
- Investigators
- Tomáš Zaoral, MD,PhD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463082
- Sponsor's protocol ID
- FNO-OPRIP-US-fluids
- Status last verified
- Dec 2022
- First submitted
- 15 Jun 2020
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators have no plan to share individual participant data with other researchers; the data will be provided upon a written request.
Publications
Unluer EE, Kara PH. Ultrasonography of jugular vein as a marker of hypovolemia in healthy volunteers. Am J Emerg Med. 2013 Jan;31(1):173-7. doi: 10.1016/j.ajem.2012.07.003. Epub 2012 Sep 11.
PubMed 22980368Bauman Z, Coba V, Gassner M, Amponsah D, Gallien J, Blyden D, Killu K. Inferior vena cava collapsibility loses correlation with internal jugular vein collapsibility during increased thoracic or intra-abdominal pressure. J Ultrasound. 2015 Sep 18;18(4):343-8. doi: 10.1007/s40477-015-0181-2. eCollection 2015 Dec.
PubMed 26550073Lu GP, Yan G, Chen Y, Lu ZJ, Zhang LE, Kissoon N. The passive leg raise test to predict fluid responsiveness in children--preliminary observations. Indian J Pediatr. 2015 Jan;82(1):5-12. doi: 10.1007/s12098-013-1303-5. Epub 2013 Dec 11.
PubMed 24327086
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Current State of Volume Status in Children by Ultrasound Measurement of Vena Cava Inferior and Vena Jugularis Interna Combined With Passive Leg Raise: a Pilot Study
- ClinicalTrials.gov ID
- NCT04463082
- Acronym / sponsor ID
- FNO-OPRIP-US-fluids
- Conditions
- Gastroenteritis, Diabetes Mellitus (Ketoacidosis)
- Keywords
- children, dehydration, ultrasound, vena cava inferior, vena jugularis, passive leg raise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- University of Ostrava
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 9 Jul 2020 (actual)
- 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.
Children with clinical signs of severe dehydration will be examined by ultrasound in a supine position during admission. Children aged between 1 and 15years will be divided into three weight groups: 10-20kg, 20-30kg, 30-50kg. Early after admission 1st measurement of diameters of vena cava inferior (VCImax, VCImin) during breathing cycles and diameters of both venae jugulares (VJI dx max, min, VJI sin max, min) before and after passive leg raise maneuver will be recorded. After a defined fluid infusion within 60 minutes, a second examination will be evaluated and compared with the first one. The investigators considered also echocardiography to measure CO changes however they wanted to make it as simple as it might be at emergency during the night shift without an experienced cardiologist.
Detailed description
Only children admitted to the hospital with clinically detectable dehydration (weight loss, dry skin, sunken eyes, no tears) will be evaluated. Weight, noninvasive blood pressure measurement, pulse rate will be recorded. Measurements would be performed with an ultrasound probe with a low frequency (2-5 MHz), a curved array transducer will be used. In the supine position, the ultrasound probe will be placed in the substernal area, in the longitudinal and transversal plane, 1 cm caudal to the confluence of the hepatic veins, and it will be operated in M-mode. The largest (VCImax) and smallest (VCImin) diameters will be measured and the collapsibility index will be calculated (according to the formula: VCImax - VCI min / VCI max x100). Immediately after this examination measurement of the right VJImax, min and the left VJImax, min will be measured again in the supine position, then after passive leg raise (lifting the lower limbs 45st. for at least 1minute ) VJImax, min. and left VJImax, min will be measured. The collapsibility index for right and left VJI would be calculated according to the formula: VJImax - VJI min / VJI max x100. After a defined fluid infusion (20ml/kg, but the maximum volume will be limited to 500ml, this means that over 25kg weight we would apply not more than 500ml) within 60 minutes. A control examination of VCI, right VJI, and left VJI will be evaluated the same way as first and compared with the previous one.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The pediatric patients will be divided into three groups, according to weight: 10-20kg, 20-30kg, 30-50kg.
| Arm | Type | Receives |
|---|---|---|
| Weight category 10-20kg | Experimental | Procedure: Intravenous administration of fluidsPediatric patients with a weight of 10-20kg will be enrolled in this arm. |
| Weight category 20-30kg | Experimental | Procedure: Intravenous administration of fluidsPediatric patients with a weight of 20-30kg will be enrolled in this arm. |
| Weight category 30-50kg | Experimental | Procedure: Intravenous administration of fluidsPediatric patients with a weight of 30-50kg will be enrolled in this arm. |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- previously healthy children
- history and clinical signs of dehydration (gastroenteritis, diabetic ketoacidosis)
Key exclusion criteria (4 listed)
- congenital heart diseases
- intestinal obstruction
- any signs of abdominal hypertension
- any illnesses known to affect the volume status
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 |
|---|---|---|
| Intravenous administration of fluidsIntravenous administration of fluids (20ml/kg, but the maximum volume will be limited up to 500ml) within 60 minutes. | Procedure or surgery | Weight category 10-20kg, Weight category 20-30kg, Weight category 30-50kg |
Primary outcome
Change in vena cava inferior diameter pre- and post-hydration
Time frame: 60 minutes
Change in vena cava inferior diameter (in millimetres) will be measured before and after hydration.
Change in vena jugularis interna diameter pre- and post-hydration (on the right side)
Time frame: 60 minutes
Change in vena jugularis interna diameter (in millimetres) will be measured before and after hydration (on the right side).
Change in vena jugularis interna diameter pre- and post-hydration (on the left side)
Time frame: 60 minutes
Change in vena jugularis interna diameter (in millimetres) will be measured before and after hydration (on the left side).
Change in collapsibility index pre- and post-hydration
Time frame: 60 minutes
Change in collapsibility index values (in per cent) will be measured before and after hydration.
1 secondary outcome
Correlation to body surface area
Time frame: 60 minutes
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 7 Dec 2022.
- Background: PubMed 22980368Unluer EE, Kara PH. Ultrasonography of jugular vein as a marker of hypovolemia in healthy volunteers. Am J Emerg Med. 2013 Jan;31(1):173-7. doi: 10.1016/j.ajem.2012.07.003. Epub 2012 Sep 11.
- Background: PubMed 26550073Bauman Z, Coba V, Gassner M, Amponsah D, Gallien J, Blyden D, Killu K. Inferior vena cava collapsibility loses correlation with internal jugular vein collapsibility during increased thoracic or intra-abdominal pressure. J Ultrasound. 2015 Sep 18;18(4):343-8. doi: 10.1007/s40477-015-0181-2. eCollection 2015 Dec.
- Background: PubMed 24327086Lu GP, Yan G, Chen Y, Lu ZJ, Zhang LE, Kissoon N. The passive leg raise test to predict fluid responsiveness in children--preliminary observations. Indian J Pediatr. 2015 Jan;82(1):5-12. doi: 10.1007/s12098-013-1303-5. Epub 2013 Dec 11.
- Individual participant dataSharing planned: No. The investigators have no plan to share individual participant data with other researchers; the data will be provided upon a written request.
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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.
Tomáš Zaoral, MD,PhD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous administration of fluids in people with Gastroenteritis and Diabetes Mellitus (Ketoacidosis), run by University Hospital Ostrava at 1 site in Czechia.
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 2 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 7 Dec 2022. 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 Czechia. 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?
Change in vena cava inferior diameter pre- and post-hydration (time frame: 60 minutes). The study lists 4 primary outcomes in all. 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 NCT04463082, which also lists 3 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 7 Dec 2022.