Renal Doppler in Pediatric Patients With Idiopathic Nephrotic Syndrome

• Sponsor: Tanta University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05912673
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 5.1
• Patients Per Site Per Month: 11.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nephrotic Syndrome	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Renal Doppler in Detection of Steroid Resistance in Pediatric Patients With Idiopathic Nephrotic Syndrome
• Actual Study Start Date: Jan 28, 2023
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Outcome Measures

Primary Outcome Measures

1. detection of steroid resistance in pediatric patients with idiopathic nephrotic syndrome [6 weeks]

   measurement of renal resistive index and detection of steroid sensetivity

Secondary Outcome Measures

1. progression of nephrotic syndrome [six months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

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: NCT05912673
• Other Study ID Numbers: 36264PR25/1/23
• First Posted: Jun 22, 2023
• Last Update Posted: Jun 22, 2023
• Last Verified: Jun 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: Yes
• Keywords provided by Sara Mabrouk Elghoul, Tanta, Stadium Street, Tanta University: renal doppler; nephrotic syndrome; steroid resistance
• Additional relevant MeSH terms: Nephrotic Syndrome; Nephrosis; Syndrome

Study Results

No Results Posted as of Jun 22, 2023