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Renal Doppler in Pediatric Patients With Idiopathic Nephrotic Syndrome

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

Study Description
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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
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
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Study Type : Observational [Patient Registry]
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Renal Doppler in Detection of Steroid Resistance in Pediatric Patients With Idiopathic Nephrotic Syndrome
Actual Study Start Date : January 28, 2023
Actual Primary Completion Date : July 30, 2023
Actual Study Completion Date : August 30, 2023
Groups and Cohorts
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Intervention Details:
  • Device: renal doppler
    Toshiba Aplio ultrasound machine and renal resistive index will be measured (peak systolic velocity- end diastolic velocity/ peak systolic velocity

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. progression of nephrotic syndrome [ Time Frame: six months ]
    frequent measurement of renal resistive index and using it as prognostic factor


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05912673


Locations
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Egypt
Sara Mabrouk Mohamed Elghoul
Tanta, Egypt
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: Sara Mabrouk Mohamed Elghoul, MD Tanta University
More Information
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Responsible Party: Sara Mabrouk Elghoul, Tanta, Stadium Street, Tanta University
ClinicalTrials.gov Identifier: NCT05912673    
Other Study ID Numbers: 36264PR25/1/23
First Posted: June 22, 2023    Key Record Dates
Last Update Posted: January 24, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 University:
renal doppler
nephrotic syndrome
steroid resistance
Additional relevant MeSH terms:
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Nephrotic Syndrome
Nephrosis
Syndrome
Disease
Pathologic Processes
Kidney Diseases
 Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases