Renal Doppler in Pediatric Patients With Idiopathic Nephrotic Syndrome

• ClinicalTrials.gov Identifier: NCT05912673
• Recruitment Status: Completed
• First Posted: June 22, 2023
• Last Update Posted: January 24, 2024
• Sponsor: Tanta University
• Information provided by (Responsible Party): Sara Mabrouk Elghoul, Tanta University

Tracking Information

• First Submitted Date: June 11, 2023
• First Posted Date: June 22, 2023
• Last Update Posted Date: January 24, 2024
• Actual Study Start Date: January 28, 2023
• Actual Primary Completion Date: July 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 8, 2023)

detection of steroid resistance in pediatric patients with idiopathic nephrotic syndrome [ Time Frame: 6 weeks ]

measurement of renal resistive index and detection of steroid sensitivity

Original Primary Outcome Measures (submitted: June 11, 2023)

detection of steroid resistance in pediatric patients with idiopathic nephrotic syndrome [ Time Frame: 6 weeks ]

measurement of renal resistive index and detection of steroid sensetivity

Current Secondary Outcome Measures (submitted: June 11, 2023)

progression of nephrotic syndrome [ Time Frame: six months ]

frequent measurement of renal resistive index and using it as prognostic factor

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Renal Doppler in Pediatric Patients With Idiopathic Nephrotic Syndrome
• Official Title: Renal Doppler in Detection of Steroid Resistance in Pediatric Patients With Idiopathic Nephrotic Syndrome
• Brief Summary: 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.
• 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 [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 6 Months
• Biospecimen: Not Provided
• 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.
• Condition: Nephrotic Syndrome

Intervention

Device: renal doppler

Toshiba Aplio ultrasound machine and renal resistive index will be measured (peak systolic velocity- end diastolic velocity/ peak systolic velocity

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 11, 2023): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 30, 2023
• Actual Primary Completion Date: July 30, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT05912673
• Other Study ID Numbers: 36264PR25/1/23
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Sara Mabrouk Elghoul, Tanta University
• Original Responsible Party: Same as current
• Current Study Sponsor: Tanta University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Tanta University
• Verification Date: January 2024