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

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: Completed
• Conditions: Fluid Volume Excess
• Intervention / Treatment: Device: lung ultrasound and electrical cardiometry

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 (Actual): 50

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Sara Mabrouk Mohamed Elghoul

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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	detection of the fluid status in pediatric patients on regular hemodialysis	six months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2023
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 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): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

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