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

December 6, 2022 updated by: University Hospital Ostrava

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70852
        • University Hospital Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Weight category 10-20kg
Pediatric patients with a weight of 10-20kg will be enrolled in this arm.
Procedure: Intravenous administration of fluids
Intravenous administration of fluids (20ml/kg, but the maximum volume will be limited up to 500ml) within 60 minutes.
Experimental: Weight category 20-30kg
Pediatric patients with a weight of 20-30kg will be enrolled in this arm.
Procedure: Intravenous administration of fluids
Intravenous administration of fluids (20ml/kg, but the maximum volume will be limited up to 500ml) within 60 minutes.
Experimental: Weight category 30-50kg
Pediatric patients with a weight of 30-50kg will be enrolled in this arm.
Procedure: Intravenous administration of fluids
Intravenous administration of fluids (20ml/kg, but the maximum volume will be limited up to 500ml) within 60 minutes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
60 minutes
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).
60 minutes
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).
60 minutes
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.
60 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Ostrava

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Ostrava

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tomáš Zaoral, MD,PhD, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FNO-OPRIP-US-fluids

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The investigators have no plan to share individual participant data with other researchers; the data will be provided upon a written request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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