Non-invasive Assessment of the Current State of Hydration in Children by Ultrasound

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Gastroenteritis, Diabetes Mellitus (Ketoacidosis)

Intervention / Treatment
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* Procedure: Intravenous administration of fluids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The pediatric patients will be divided into three groups, according to weight: 10-20kg, 20-30kg, 30-50kg.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight category 10-20kg<br>Pediatric patients with a weight of 10-20kg will be enrolled in this arm. | Procedure: Intravenous administration of fluids<br>* Intravenous administration of fluids (20ml/kg, but the maximum volume will be limited up to 500ml) within 60 minutes.<br>|
| Experimental: Weight category 20-30kg<br>Pediatric patients with a weight of 20-30kg will be enrolled in this arm. | Procedure: Intravenous administration of fluids<br>* Intravenous administration of fluids (20ml/kg, but the maximum volume will be limited up to 500ml) within 60 minutes.<br>|
| Experimental: Weight category 30-50kg<br>Pediatric patients with a weight of 30-50kg will be enrolled in this arm. | Procedure: Intravenous administration of fluids<br>* Intravenous administration of fluids (20ml/kg, but the maximum volume will be limited up to 500ml) within 60 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, dehydration, ultrasound, vena cava inferior, vena jugularis, passive leg raise