Acute Renal FailureNCT02139059
Delayed or Direct Ureteroscopy in the Treatment of Pediatric Calcular Anuria
A study testing initial urinary drainage and direct ureteroscopy in people with Acute Renal Failure and Anuria, run by Cairo University at 2 sites in Egypt.
Trial summary
To compare staged ureteroscopy following initial urinary drainage versus direct ureteroscopy without initial urinary drainage in the treatment of obstructive calcular anuria with acute renal failure in children. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Acute Renal Failure, Anuria, Obstructive Uropathy
- What is being tested?
- initial urinary drainage and direct ureteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- Jun 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children ≤12 years old presenting with Obstructive Anuria and Acute Renal Failure due to bilateral ureteric stones suitable for ureteroscopy.
Who cannot join
- Fever, pyonephrosis or sepsis.
- unstable patients are stabilized first by dialysis.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Cairo University Hospitals
Cairo, 12222
Mohammed S ElSheemy, A Professor
- Not yet recruiting
Cairo University Hospitals
Cairo, 12222
About this study
Official title: Staged Ureteroscopy After Initial Urinary Drainage Versus Direct Ureteroscopy in the Treatment of Pediatric Obstructive Calcular Anuria
To compare staged ureteroscopy following initial urinary drainage versus direct ureteroscopy without initial urinary drainage in the treatment of obstructive calcular anuria with acute renal failure in children.
Read the detailed description
To compare staged ureteroscopy following initial urinary drainage and stabilization of renal functions using percutaneous nephrostomy or double J stent versus direct ureteroscopy without initial urinary drainage in the treatment of obstructive calcular anuria with acute renal failure due to ureteric calculi in children.
- Conditions
- Acute Renal Failure, Anuria, Obstructive Uropathy, Ureteric Stones
- Being tested
- initial urinary drainage, direct ureteroscopy
- Keywords
- anuria, children, ureteroscopy, initial urinary drainage, ureteric stones
- Medical subject headings
- Acute Kidney Injury, Anuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
initial urinary drainageProcedure or surgery
initial urinary drainage is done using nephrostomy or double J stent to stabilize renal functions. this is followed several days later by definitive ureteroscopy.
direct ureteroscopyProcedure or surgery
direct ureteroscopy is done without initial urinary drainage and before return to normal chemistry. this is followed follow-up of renal functions for several days before treatment of the contralateral side.
| Study group | Role | What they receive |
|---|---|---|
| initial urinary drainage | Active comparator | initial urinary drainage to stabilize renal functions before ureteroscopy Receives: Procedure: initial urinary drainage |
| direct ureteroscopy | Active comparator | direct ureteroscopy without initial urinary drainage Receives: Procedure: direct ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to normal creatinine
period for return to normal creatinine in both groups
Measured: 1 week
stone free status
success in removal of ureteric stones using ureteroscopy
Measured: 1 week
operative and early post operative complications
Hematuria, Extravasation (perforation), mucosal complications, stone migration, failure of ureteric access, fever
Measured: 1 week
Secondary outcomes (3)
ureteric stricture
occurrence of ureteric stricture as a delayed complication
Measured: 6 months
period to reach stone free status bilaterally
period to reach stone free status bilaterally after the treatment of the contralateral side
Measured: 6 months
number of times of exposure to general anesthesia
number of times of exposure to general anesthesia during successive interventions to clear stones bilaterally
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammed said elsheemy, Cairo University
- Investigators
- Mohammed S ElSheemy, A professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139059
- Sponsor's protocol ID
- 61179
- Status last verified
- Feb 2015
- First submitted
- 13 May 2014
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staged Ureteroscopy After Initial Urinary Drainage Versus Direct Ureteroscopy in the Treatment of Pediatric Obstructive Calcular Anuria
- ClinicalTrials.gov ID
- NCT02139059
- Acronym / sponsor ID
- 61179
- Conditions
- Acute Renal Failure, Anuria, Obstructive Uropathy, Ureteric Stones
- Keywords
- anuria, children, ureteroscopy, initial urinary drainage, ureteric stones
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 15 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare staged ureteroscopy following initial urinary drainage versus direct ureteroscopy without initial urinary drainage in the treatment of obstructive calcular anuria with acute renal failure in children.
Detailed description
To compare staged ureteroscopy following initial urinary drainage and stabilization of renal functions using percutaneous nephrostomy or double J stent versus direct ureteroscopy without initial urinary drainage in the treatment of obstructive calcular anuria with acute renal failure due to ureteric calculi in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| initial urinary drainage | Active comparator | Procedure: initial urinary drainageinitial urinary drainage to stabilize renal functions before ureteroscopy |
| direct ureteroscopy | Active comparator | Procedure: direct ureteroscopydirect ureteroscopy without initial urinary drainage |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children ≤12 years old presenting with Obstructive Anuria and Acute Renal Failure due to bilateral ureteric stones suitable for ureteroscopy.
Key exclusion criteria (2 listed)
- Fever, pyonephrosis or sepsis.
- unstable patients are stabilized first by dialysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| initial urinary drainageinitial urinary drainage is done using nephrostomy or double J stent to stabilize renal functions. this is followed several days later by definitive ureteroscopy. | Procedure or surgery | initial urinary drainage |
| direct ureteroscopydirect ureteroscopy is done without initial urinary drainage and before return to normal chemistry. this is followed follow-up of renal functions for several days before treatment of the contralateral side. | Procedure or surgery | direct ureteroscopy |
Primary outcome
Return to normal creatinine
Time frame: 1 week
period for return to normal creatinine in both groups
stone free status
Time frame: 1 week
success in removal of ureteric stones using ureteroscopy
operative and early post operative complications
Time frame: 1 week
Hematuria, Extravasation (perforation), mucosal complications, stone migration, failure of ureteric access, fever
3 secondary outcomes
ureteric stricture
Time frame: 6 months
period to reach stone free status bilaterally
Time frame: 6 months
number of times of exposure to general anesthesia
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed S ElSheemy, A professor principal investigator
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing initial urinary drainage and direct ureteroscopy in people with Acute Renal Failure and Anuria, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed S ElSheemy, A Professor (01006117755, mohammedshemy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to normal creatinine (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2015.