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

University Hospital Ostrava

Status: Completed

Conditions: Diabetes Mellitus (Ketoacidosis); Gastroenteritis

Treatments: Procedure: Intravenous administration of fluids

Study type: Interventional

Funder types: Other

Identifiers

NCT04463082

FNO-OPRIP-US-fluids

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 1 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 3 patient groups

Weight category 10-20kg

Experimental group

Description:

Pediatric patients with a weight of 10-20kg will be enrolled in this arm.

Treatment:

Procedure: Intravenous administration of fluids

Weight category 20-30kg

Experimental group

Description:

Pediatric patients with a weight of 20-30kg will be enrolled in this arm.

Treatment:

Procedure: Intravenous administration of fluids

Weight category 30-50kg

Experimental group

Description:

Pediatric patients with a weight of 30-50kg will be enrolled in this arm.

Treatment:

Procedure: Intravenous administration of fluids