Non-invasive Assessment of the Current State of Hydration in Children by Ultrasound
- Conditions
- GastroenteritisDiabetes Mellitus (Ketoacidosis)
- Interventions
- Procedure: Intravenous administration of fluids
- Registration Number
- NCT04463082
- Lead Sponsor
- University Hospital Ostrava
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- previously healthy children
- history and clinical signs of dehydration (gastroenteritis, diabetic ketoacidosis)
- congenital heart diseases
- intestinal obstruction
- any signs of abdominal hypertension
- any illnesses known to affect the volume status
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Weight category 10-20kg Intravenous administration of fluids Pediatric patients with a weight of 10-20kg will be enrolled in this arm. Weight category 30-50kg Intravenous administration of fluids Pediatric patients with a weight of 30-50kg will be enrolled in this arm. Weight category 20-30kg Intravenous administration of fluids Pediatric patients with a weight of 20-30kg will be enrolled in this arm.
- Primary Outcome Measures
Name Time Method Change in vena jugularis interna diameter pre- and post-hydration (on the right side) 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) 60 minutes Change in vena jugularis interna diameter (in millimetres) will be measured before and after hydration (on the left side).
Change in vena cava inferior diameter pre- and post-hydration 60 minutes Change in vena cava inferior diameter (in millimetres) will be measured before and after hydration.
Change in collapsibility index pre- and post-hydration 60 minutes Change in collapsibility index values (in per cent) will be measured before and after hydration.
- Secondary Outcome Measures
Name Time Method Correlation to body surface area 60 minutes All obtained parameters from the other Outcome Measures will be correlated to the body surface area of the patient (measured in m2)
Trial Locations
- Locations (1)
University Hospital Ostrava
🇨🇿Ostrava, Moravian-Silesian Region, Czechia