Lung Ultrasound Versus Cardiometry in Detection of Extravascular Lung Water in Pediatric Patients on Hemodialysis.

July 12, 2023 updated by: Sara Mabrouk Elghoul, Tanta University
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
      • Tanta, Egypt
        • Recruiting
        • Sara Mabrouk Mohamed Elghoul
        • Contact:

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

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
volume status in pediatric patients on regular hemodialysis
Time Frame: six months
detection of the fluid status in pediatric patients on regular hemodialysis
six months

Collaborators and Investigators

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

Sponsor

Tanta University

Investigators

  • Principal Investigator: Sara Mabrouk Mohamed Elghoul, MD, Tanta University

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)

May 5, 2023

Primary Completion (Estimated)

September 30, 2023

Study Completion (Estimated)

October 30, 2023

Study Registration Dates

First Submitted

June 17, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 36264PR187/4/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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