- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03695991
Effect of Per-cutaneous Nephrosotomy Drainage on Radioisotope Imaging of Hydronephrotic Kidneys
April 12, 2019 updated by: Abdelrahman Atef Ali, Assiut University
Hydronephrosis describes a condition of urine-filled dilation of the collecting system.
Normally, urine flows through the urinary tract with minimal or low pressure.
If the build-up of excess fluid in the urinary collecting system continues, there will be an increase in pressure and atrophy of renal cortex.
If hydronephrosis is left untreated for a long time, renal damage with permanent loss of function occurs
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
62
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients will be recruited from out-patient clinics and in-patient sectors of Assiut Urology and Nephrology hospital
Description
Inclusion Criteria:
- 1) Patients for whom a percutaneous nephrostomy is indicated provided that the hydronephrosis is advanced ( parenchymal thickness not more than 5 mm ) 2) Patients for whom a nephrectomy is planned for a seemingly poorly functioning kidney along with either
Exclusion Criteria:
- Target kidney is the only functioning or better functioning kidney or otherwise substantially contributing to the total renal function, so nephrectomy is not likely.
- Emergency cases where the general condition of the patient cannot withstand the logistics of undergoing a radioisotope study eg
- Malignancy in the target kidney
- Patients unlikely to undergo a nephrectomy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study group
Patients will be recruited from out-patient clinics and in-patient sectors of Assiut Urology and Nephrology hospital
|
The percutaneous nephrostomy will be done under sonographic or fluoroscopic guidance.
Establishment of intravenous access and antibiotics will be performed half an hour prior to procedure particularly in patients presenting with urinary tract infection.
The procedure will be done under local anesthesia but general anesthesia may be used for uncooperative patients.
percutaneous nephrostomy will be performed in the prone position, however, in case of relative contraindication to prone position
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The rate of increase in glomerular filtration rate after intervention
Time Frame: 3 weeks
|
the radioisotope measurement of glomerular filtration rate will be done before and after insertion of percutaneous nephrostomy tube
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2019
Primary Completion (Anticipated)
October 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
October 3, 2018
First Submitted That Met QC Criteria
October 3, 2018
First Posted (Actual)
October 4, 2018
Study Record Updates
Last Update Posted (Actual)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 12, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCNHK
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hydronephrosis
-
Rush University Medical CenterCompletedCongenital HydronephrosisUnited States
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-
Mansoura UniversityActive, not recruitingRenal Function Disorder | Pediatric Disorder | Hydronephrosis, Secondary | Hydronephrosis in Children | Hydronephrosis Congenital | Bladder-Neck; Obstruction, Congenital | Urethral ValveEgypt
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The Children's Hospital of Zhejiang University...Not yet recruitingPediatric | Congenital Hydronephrosis | UTD Grading System | Natural ProgressionChina
-
Cairo UniversityCompletedPyeloplasty | Obstructive Uropathy | Pelviureteric Junction Obstruction | Neonatal Hydronephrosis | Urinary StentEgypt
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Alrijne HospitalCompletedKidney Diseases | Urologic Diseases | Kidney Calculi | Urinary Calculi | Urolithiasis | Stone Ureter | Stone, Kidney | Urinary Stone | Pyelonephritis | Hydronephrosis | Obstruction | Kidney Failure, Acute | Ureter Obstruction | Urinary Obstruction | Kidney Dysfunction | Kidney Insufficiency | Pyelonephritis Acute | Stone, Urinary and other conditionsNetherlands
-
Nottingham University Hospitals NHS TrustCompleted
Clinical Trials on percutaneous nephrostomy
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-
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-
TC Erciyes UniversityCompleted
-
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-
Beni-Suef UniversityRecruitingAcute Kidney Injury | Obstructive Uropathy | Calculous Anuria | Upper Ureteral StoneEgypt
-
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-
The University of Texas Health Science Center,...Withdrawn
-
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-
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-
Academisch Medisch Centrum - Universiteit van Amsterdam...Alrijne HospitalCompletedKidney Diseases | Urologic Diseases | Kidney Calculi | Urinary Calculi | Urolithiasis | Stone Ureter | Stone, Kidney | Urinary Stone | Pyelonephritis | Hydronephrosis | Obstruction | Kidney Failure, Acute | Ureter Obstruction | Urinary Obstruction | Kidney Dysfunction | Kidney Insufficiency | Pyelonephritis Acute | Stone, Urinary and other conditionsNetherlands