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Completed

NCT Number: NCT04463082

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

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.

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Key information

Conditions

Gastroenteritis Acid-Base Imbalance Acidosis Dehydration Diabetes Mellitus Diabetes Mellitus (Ketoacidosis) Digestive System Diseases Endocrine System Diseases Gastrointestinal Diseases Glucose Metabolism Disorders Ketosis Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Water-Electrolyte Imbalance

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous administration of fluids

Procedure

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

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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.

Secondary outcomes

  1. Correlation to body surface area

    Time frame: 60 minutes

    All obtained parameters from the other Outcome Measures will be correlated to the body surface area of the patient (measured in m2)

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Collaborators

  • University of Ostrava

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 9, 2020
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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