Renal Doppler in Pediatric Patients With Idiopathic Nephrotic Syndrome

Renal Doppler in Detection of Steroid Resistance in Pediatric Patients With Idiopathic Nephrotic Syndrome

The use of the renal resistive index in pediatric patient with idiopathic nephrotic syndrome to detect steroid resistance and to use it as a prognostic instrument of the progression of the disease.

Study Overview

• Status: Completed
• Conditions: Nephrotic Syndrome
• Intervention / Treatment: Device: renal doppler

Detailed Description

Renal Doppler will be done for all children in supine and lateral positions using Toshiba Aplio ultrasound machine and renal resistive index will be measured (peak systolic velocity- end diastolic velocity/ peak systolic velocity) at diagnosis, after one month, 3 months and 6months, in which these values will be obtained by the ultrasound machine based on the computer algorithm. Also the kidneys will be scanned firstly for length, width, cortical thickness and echogenicity.

• Study Type: Observational
• Enrollment (Actual): 60

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: Probability Sample

Study Population

60 children and adolescents with nephrotic syndrome who will be diagnosed and followed at our nephrology Unit and Clinic at TUH during the period of the study.

Description

Inclusion Criteria:

• Pediatric patients with primary nephrotic syndrome aged from 1 to 18 years

Exclusion Criteria:

• - Patients with congenital nephrotic syndrome.
• Patients with secondary causes of nephrotic syndrome.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
detection of steroid resistance in pediatric patients with idiopathic nephrotic syndrome	measurement of renal resistive index and detection of steroid sensitivity	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression of nephrotic syndrome	frequent measurement of renal resistive index and using it as prognostic factor	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): January 28, 2023
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: June 11, 2023
• First Submitted That Met QC Criteria: June 11, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: nephrotic syndrome; steroid resistance; renal doppler
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Syndrome; Nephrotic Syndrome; Nephrosis
• Other Study ID Numbers: 36264PR25/1/23

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: Yes