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

Primary Purpose

Gastroenteritis, Diabetes Mellitus (Ketoacidosis)

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Intravenous administration of fluids
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroenteritis focused on measuring children, dehydration, ultrasound, vena cava inferior, vena jugularis, passive leg raise

Eligibility Criteria

1 Year - 15 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Ostrava

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Weight category 10-20kg

Weight category 20-30kg

Weight category 30-50kg

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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).
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).
Change in collapsibility index pre- and post-hydration
Change in collapsibility index values (in per cent) will be measured before and after hydration.

Secondary Outcome Measures

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)

Full Information

First Posted
June 15, 2020
Last Updated
December 6, 2022
Sponsor
University Hospital Ostrava
Collaborators
University of Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT04463082
Brief Title
Non-invasive Assessment of the Current State of Hydration in Children by Ultrasound
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
Collaborators
University of Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteritis, Diabetes Mellitus (Ketoacidosis)
Keywords
children, dehydration, ultrasound, vena cava inferior, vena jugularis, passive leg raise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The pediatric patients will be divided into three groups, according to weight: 10-20kg, 20-30kg, 30-50kg.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weight category 10-20kg
Arm Type
Experimental
Arm Description
Pediatric patients with a weight of 10-20kg will be enrolled in this arm.
Arm Title
Weight category 20-30kg
Arm Type
Experimental
Arm Description
Pediatric patients with a weight of 20-30kg will be enrolled in this arm.
Arm Title
Weight category 30-50kg
Arm Type
Experimental
Arm Description
Pediatric patients with a weight of 30-50kg will be enrolled in this arm.
Intervention Type
Procedure
Intervention Name(s)
Intravenous administration of fluids
Intervention Description
Intravenous administration of fluids (20ml/kg, but the maximum volume will be limited up to 500ml) within 60 minutes.
Primary Outcome Measure Information:
Title
Change in vena cava inferior diameter pre- and post-hydration
Description
Change in vena cava inferior diameter (in millimetres) will be measured before and after hydration.
Time Frame
60 minutes
Title
Change in vena jugularis interna diameter pre- and post-hydration (on the right side)
Description
Change in vena jugularis interna diameter (in millimetres) will be measured before and after hydration (on the right side).
Time Frame
60 minutes
Title
Change in vena jugularis interna diameter pre- and post-hydration (on the left side)
Description
Change in vena jugularis interna diameter (in millimetres) will be measured before and after hydration (on the left side).
Time Frame
60 minutes
Title
Change in collapsibility index pre- and post-hydration
Description
Change in collapsibility index values (in per cent) will be measured before and after hydration.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Correlation to body surface area
Description
All obtained parameters from the other Outcome Measures will be correlated to the body surface area of the patient (measured in m2)
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomáš Zaoral, MD,PhD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators have no plan to share individual participant data with other researchers; the data will be provided upon a written request.
Citations:
PubMed Identifier
22980368
Citation
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.
Results Reference
background
PubMed Identifier
26550073
Citation
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.
Results Reference
background
PubMed Identifier
24327086
Citation
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.
Results Reference
background

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

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