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

NCT04463082 | Completed

• 1 other identifier: FNO-OPRIP-US-fluids
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroenteritis; Diabetes Mellitus (Ketoacidosis)

Keywords

children; dehydration; ultrasound; vena cava inferior; vena jugularis; passive leg raise

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Correlation to body surface area

  60 minutes

Study Arms (3)

Weight category 10-20kg

EXPERIMENTAL

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

Procedure: Intravenous administration of fluids

Weight category 20-30kg

EXPERIMENTAL

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

Procedure: Intravenous administration of fluids

Weight category 30-50kg

EXPERIMENTAL

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

Procedure: Intravenous administration of fluids

Interventions

Intravenous administration of fluids PROCEDURE

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

Weight category 10-20kg; Weight category 20-30kg; Weight category 30-50kg

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• previously healthy children
• history and clinical signs of dehydration (gastroenteritis, diabetic ketoacidosis)

You may not qualify if:

• congenital heart diseases
• intestinal obstruction
• any signs of abdominal hypertension
• any illnesses known to affect the volume status

Sponsors & Collaborators

• University Hospital Ostrava: lead
• University of Ostrava: collaborator

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related Publications (3)

• 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.

  PMID: 22980368 BACKGROUND

• 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.

  PMID: 26550073 BACKGROUND

• 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.

  PMID: 24327086 BACKGROUND

MeSH Terms

Conditions

Gastroenteritis; Diabetes Mellitus; Ketosis; Dehydration

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Acidosis; Acid-Base Imbalance; Water-Electrolyte Imbalance; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tomáš Zaoral, MD,PhD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The pediatric patients will be divided into three groups, according to weight: 10-20kg, 20-30kg, 30-50kg.

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: July 9, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)