Fluid Volume ExcessNCT05943717
Lung Ultrasound Versus Cardiometry in Detection of Extravascular Lung Water in Pediatric Patients on Hemodialysis.
An observational study of Fluid Volume Excess, run by Tanta University at 1 site in Egypt.
Trial summary
Comparing the efficacy of both lung ultrasound and electrical cardiometry to detect the extravascular lung water and volume status in pediatric patients on regular hemodialysis and use them as non-invasive methods for early detection of hypervolemia or euvolemia even before appearance of clinical symptoms to decrease… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Fluid Volume Excess
- What is being tested?
- lung ultrasound and electrical cardiometry
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2023to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 50 children and adolescents with end stage renal disease on regular hemodialysis for three times weekly at TUH during the period of the study. Inclusion criteria: Pediatric patients with end stage renal disease aged from 5 to 18 years on regular hemodialysis. Exclusion criteria: * Patients with coexisting lung fibrosis, atelectasis, and interstitial lung disease. * Patients with heart failure. * Patients with implantable cardiac pacemaker or defibrillator.
Who may be able to join
- Pediatric patients with end stage renal disease aged from 5 to 18 years on regular hemodialysis
Who cannot join
- Patients with coexisting lung fibrosis, atelectasis, and interstitial lung disease.
- Patients with heart failure.
- Patients with implantable cardiac pacemaker or defibrillator
Trial locations and contacts
1 site in 1 country.
About this study
Comparing the efficacy of both lung ultrasound and electrical cardiometry to detect the extravascular lung water and volume status in pediatric patients on regular hemodialysis and use them as non-invasive methods for early detection of hypervolemia or euvolemia even before appearance of clinical symptoms to decrease morbidity and mortality
Read the detailed description
This cross sectional study will be conducted to compare between the efficacy of both lung ultrasound and electrical cardiometry to detect the extravascular lung water and volume status in pediatric patients on regular hemodialysis and use them as a non-invasive method for early detection of hypervolemia or euvolemia even before appearance of clinical symptoms of both conditions.
- Conditions
- Fluid Volume Excess
- Being tested
- lung ultrasound and electrical cardiometry
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasound and electrical cardiometryDevice
: B-lines of lung ultrasound and the parameters of cardiometry will be measured at the mid-week HD session before starting the session by 30 min then every 30min during HD session for 180 min and then after the end of the session of HD by 30 min and then The specificity and sensitivity of both techniques will be compared to each other
| Study group | Role | What they receive |
|---|---|---|
| 50 children and adolescents with end stage renal disease on regular hemodialysis | 50 children and adolescents with end stage renal disease on regular hemodialysis for three times weekly Receives: Device: lung ultrasound and electrical cardiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume status in pediatric patients on regular hemodialysis
detection of the fluid status in pediatric patients on regular hemodialysis
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start5 May 2023
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid Volume ExcessStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mabrouk Elghoul, Tanta University
- Investigators
- Sara Mabrouk Mohamed Elghoul, MD, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943717
- Sponsor's protocol ID
- 36264PR187/4/23
- Status last verified
- May 2024
- First submitted
- 17 Jun 2023
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound Versus Cardiometry in Detection of Extravascular Lung Water in Pediatric Patients on Hemodialysis.
- ClinicalTrials.gov ID
- NCT05943717
- Acronym / sponsor ID
- 36264PR187/4/23
- Conditions
- Fluid Volume Excess
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing the efficacy of both lung ultrasound and electrical cardiometry to detect the extravascular lung water and volume status in pediatric patients on regular hemodialysis and use them as non-invasive methods for early detection of hypervolemia or euvolemia even before appearance of clinical symptoms to decrease morbidity and mortality
Detailed description
This cross sectional study will be conducted to compare between the efficacy of both lung ultrasound and electrical cardiometry to detect the extravascular lung water and volume status in pediatric patients on regular hemodialysis and use them as a non-invasive method for early detection of hypervolemia or euvolemia even before appearance of clinical symptoms of both conditions.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 50 children and adolescents with end stage renal disease on regular hemodialysis | – | Device: lung ultrasound and electrical cardiometry50 children and adolescents with end stage renal disease on regular hemodialysis for three times weekly |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 50 children and adolescents with end stage renal disease on regular hemodialysis for three times weekly at TUH during the period of the study. Inclusion criteria: Pediatric patients with end stage renal disease aged from 5 to 18 years on regular hemodialysis. Exclusion criteria: * Patients with coexisting lung fibrosis, atelectasis, and interstitial lung disease. * Patients with heart failure. * Patients with implantable cardiac pacemaker or defibrillator.
Key inclusion criteria (1 listed)
- Pediatric patients with end stage renal disease aged from 5 to 18 years on regular hemodialysis
Key exclusion criteria (3 listed)
- Patients with coexisting lung fibrosis, atelectasis, and interstitial lung disease.
- Patients with heart failure.
- Patients with implantable cardiac pacemaker or defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lung ultrasound and electrical cardiometry: B-lines of lung ultrasound and the parameters of cardiometry will be measured at the mid-week HD session before starting the session by 30 min then every 30min during HD session for 180 min and then after the end of the session of HD by 30 min and then The specificity and sensitivity of both techniques will be compared to each other | Device | 50 children and adolescents with end stage renal disease on regular hemodialysis |
Primary outcome
volume status in pediatric patients on regular hemodialysis
Time frame: six months
detection of the fluid status in pediatric patients on regular hemodialysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: No
Related trials for Fluid Volume Excess
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Recruiting
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Chronic Heart Failure, CKD Stage 3
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Mabrouk Mohamed Elghoul, MD principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Volume Excess, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volume status in pediatric patients on regular hemodialysis (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.