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

• Sponsor: Tanta University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05943717
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 5.8
• Patients Per Site Per Month: 8.5

Study Details

Study Description

Brief 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 morbidity and mortality

Condition or Disease	Intervention/Treatment	Phase
Fluid Volume Excess	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 Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Lung Ultrasound Versus Cardiometry in Detection of Extravascular Lung Water in Pediatric Patients on Hemodialysis.
• Actual Study Start Date: May 5, 2023
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Oct 30, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. volume status in pediatric patients on regular hemodialysis [six months]

   detection of the fluid status in pediatric patients on regular hemodialysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sara Mabrouk Mohamed Elghoul	Tanta		Egypt

Sponsors and Collaborators

• Tanta University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sara Mabrouk Elghoul, Tanta, Stadium Street, Tanta University
• ClinicalTrials.gov Identifier: NCT05943717
• Other Study ID Numbers: 36264PR187/4/23
• First Posted: Jul 13, 2023
• Last Update Posted: Jul 13, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 13, 2023