Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04463082
Other study ID # FNO-OPRIP-US-fluids
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date October 1, 2021

Study information

Verified date December 2022
Source University Hospital Ostrava
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 1, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Year to 15 Years
Eligibility Inclusion Criteria: - previously healthy children - history and clinical signs of dehydration (gastroenteritis, diabetic ketoacidosis) Exclusion Criteria: - congenital heart diseases - intestinal obstruction - any signs of abdominal hypertension - any illnesses known to affect the volume status

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Intravenous administration of fluids
Intravenous administration of fluids (20ml/kg, but the maximum volume will be limited up to 500ml) within 60 minutes.

Locations

Country Name City State
Czechia University Hospital Ostrava Ostrava Moravian-Silesian Region

Sponsors (2)

Lead Sponsor Collaborator
University Hospital Ostrava University of Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (3)

Bauman 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. — View Citation

Lu 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 60 minutes
Primary 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). 60 minutes
Primary 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). 60 minutes
Primary Change in collapsibility index pre- and post-hydration Change in collapsibility index values (in per cent) will be measured before and after hydration. 60 minutes
Secondary 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) 60 minutes
See also
  Status Clinical Trial Phase
Completed NCT01168401 - Bivalent Norovirus Vaccine Study Phase 1
Completed NCT02541695 - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli N/A
Completed NCT02473887 - Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting Phase 1
Completed NCT01911143 - A Retrospective, Blinded Validation of a Host-response Based Diagnostics N/A
Not yet recruiting NCT01671137 - Probiotic for the Prevention of Functional Disorders in Childhood N/A
Completed NCT01917461 - Observational, Prospective Clinical Study to Evaluate Biomarkers as Indicators of Acute Bacterial or Viral Infections N/A
Withdrawn NCT00691275 - Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration N/A
Recruiting NCT06025695 - Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks Phase 3
Completed NCT02497417 - A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients N/A
Active, not recruiting NCT03000296 - Autologous Unselected Hematopoietic Stem Cell Transplantation for Refractory Crohn's Disease N/A
Completed NCT01225042 - The Effect of Probiotics on E. Coli Gastroenteritis N/A
Completed NCT01236066 - Impact of Rotavirus Vaccination on Hospitalisations for Rotavirus Gastroenteritis in Children Aged <5 Years in Australia N/A
Recruiting NCT00987519 - Viral Respiratory and Gastrointestinal Infections in Children Under 6 Years of Age N/A
Terminated NCT01357174 - ROTATEQâ„¢ Post-Marketing Surveillance in the Philippines N/A
Completed NCT01033799 - Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers N/A
Recruiting NCT01363726 - Surveillance of Rotavirus Gastroenteritis in Children <5 Years N/A
Completed NCT00130832 - Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED) Phase 3
Terminated NCT02568189 - Utility of Ultrasound Assessment of the Inferior Vena Cava in Patients With Sepsis and Dehydration N/A
Terminated NCT02165813 - Oral Nitazoxanide in Acute Gastroenteritis in Australian Indigenous Children Phase 2/Phase 3
Completed NCT01853124 - Emergency Department Probiotic Treatment of Pediatric Gastroenteritis Phase 3