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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004022-41 | EudraCT Number |
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Randomized control trial to compare the efficacy and safety of percutaneous nephrostomy with retrograde ureteric stenting for emergency renal decompression in cases of obstruction and sepsis associated with ureteric calculi.
The obstructed kidney in the setting of urosepsis is a urological emergency. Stone manipulation in the setting of active, untreated infection with concomitant urinary tract obstruction can lead to life-threatening sepsis. Therefore, urgent decompression of the collecting system is warranted.
There are two options for urgent decompression of an obstructed collecting system:
This strategy allows drainage of infected urine and penetration of antibiotics to the affected renal unit. Definitive stone manipulation should be delayed until the infection is cleared following an appropriate course of antimicrobial therapy.
Both the European Association of Urology (EAU) and the American Urological Association (AUA) provide guidelines for management of an obstructed kidney. Both organisations provide evidence-based statements of the highest recommendation that urgent decompression of the kidney is mandated in the setting of sepsis. However, neither organisation recommend one decompression modality over the other. There is a lack of high quality up-to-date evidence to support a consensus view that one method of decompression is superior to the other.
This study aims to determine the most effective method of renal decompression in cases of obstruction and sepsis associated with ureteric calculi.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCN | Experimental | Percutaneous nephrostomy |
|
| JJ Stent | Experimental | Retrograde ureteric JJ stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous nephrostomy | Procedure | Percutaneous nephrostomy tube insertion under radiological guidance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to normalisation of white cell count and/or temperature | Within 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Within 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Adelaide and Meath Hospital, incorporating The National Children's Hospital | Tallaght | Dublin | Ireland | |||
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| ID | Term |
|---|---|
| D053039 | Ureterolithiasis |
| D018805 | Sepsis |
| D006869 | Hydronephrosis |
| ID | Term |
|---|---|
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D009403 | Nephrostomy, Percutaneous |
| ID | Term |
|---|---|
| D003950 | Diagnostic Techniques, Urological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D010030 | Ostomy |
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| Retrograde ureteric JJ stent | Procedure | Retrograde ureteric JJ stent insertion using cystoscopy |
|
| St. James's Hospital |
| Dublin |
| Ireland |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
| D013514 | Surgical Procedures, Operative |
| D000074643 | Nephrotomy |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D014547 | Urinary Diversion |