Kidney Diseases Clinical Trial
— STONEOfficial title:
Effectiveness of Drainage of the Kidney by Percutaneous Nephrostomy Catheter Placement Vs. Retrograde Double J Catheter Placement in Patients With Symptoms of Obstructive Kidney Disease Caused by Urolithiasis
Verified date | February 2024 |
Source | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigate the effectiveness of percutaneous nephrostomy catheter placement versus retrograde double J catheter placement in patients with symptoms of obstructive kidney disease (with either infection and/or pain and/or kidney function deterioration) caused by urolithiasis.
Status | Completed |
Enrollment | 204 |
Est. completion date | January 1, 2024 |
Est. primary completion date | January 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - In order to be considered eligible to participate in this study, a subject must meet all of the following criteria: - Male/female >18 year - Symptoms and/or laboratory results indicating obstructive kidney disease with or without infection. - A kidney or ureteral stone is present on ultrasound or CT (max 3 months old prior to presentation) - Both drainage techniques are feasible and safe in opinion of the treating physician (from logistics point of view and in the best interest of the patient). - Willing and able to comply with filling in questionnaires and follow-up regiment Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Analphabetic or not mastering the Dutch language - Pregnancy - Usage of anticoagulation agents other than acetylsalicylic acid. - Contraindication for either technique looking at history and anatomy (e.g. kidney transplant, pouch, Bricker deviation, urethral or ureteral stenosis) |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam UMC, location AMC | Amsterdam | Noord Holland |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Alrijne Hospital |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | time (hours) to clinical recovery regarding infection | Unit is hours (0-8), higher scores mean a worse outcome. Clinical recovery is defined as reaching one or more of the following criteria (all criteria are added seperately)
- If indication for drainage is infection clinical recovery is defined as: improvement of infection, indicated by a decrease of WBC (unit: mm3) in two executive laboratory results and at least below 15.000 mm3. |
3 months | |
Primary | time (hours) to clinical recovery regarding infection | Unit is hours (0-8), higher scores mean a worse outcome. Clinical recovery is defined as reaching one or more of the following criteria (all criteria are added seperately)
- If indication for drainage is infection clinical recovery is defined as: improvement of infection, indicated by a body temperatur between 36.0-38.5 °Celsius. and/or If indication for drainage is untreatable pain: Numeric rating score (NRS) considering pain resulting from a renal colic is improved and < 3 points and/or If indication for drainage is deterioration of kidney function: improvement of creatinine/ Glomerular Filtration Rate (GFR) in two executive laboratory results |
3 months | |
Primary | time (hours) to clinical recovery regarding pain | Unit is hours (0-8), higher scores mean a worse outcome. Clinical recovery is defined as reaching one or more of the following criteria (all criteria are added seperately) If indication for drainage is untreatable pain clinical recover is defined as: Numeric Rating Score (NRS) considering pain resulting from a renal colic is improved and < 3 points (higher scores mean greater level of pain). | 3 months | |
Primary | time (in hours) to clinical recovery regarding kidney function | Unit is hours (0-8), higher scores mean a worse outcome. Clinical recovery is defined as reaching one or more of the following criteria (all criteria are added seperately) If indication for drainage is deterioration of kidney function: improvement of creatinine (µmol/L) and/or Glomerular Filtration Rate (ml/min/1.73 m2) in two executive laboratory results. | 3 months | |
Secondary | patient reported outcome measures (PROMS) quality of life | EQ-5D-5L questionnaire (range 0-1; greater scores reflect a higher quality of life). | 3 months | |
Secondary | patient reported outcome measures (PROMS) pain score | Numeric Rating Score (NRS) considering pain questionnaire (range 0-10; greater scores reflect higher pain levels) | 3 months | |
Secondary | patient reported outcome measures (PROMS) satisfaction | satisfaction scale (range 0-10; greater scores reflect higher levels of satisfaction) | 3 months | |
Secondary | patient reported outcome measures (PROMS) catheter related problems | catheter questionnaire. All answers will be analysed using frequencies. No score is applicable. | 3 months | |
Secondary | patient reported outcome measures (PROMS) cost and productivity | disease-specified iMCQ (Medical Consumption Questionnaire)/iPCQ (Productivity Cost Questionnaire). All answers will be analyzed using frequencies and will be used in economical models to calculate productivity burden and societal and individual costs. | 3 months | |
Secondary | patient reported outcome measures (PROMS) on costs iMCQ (Medical consumption questionnaire) | disease-specified iMCQ (Medical Consumption Questionnaire). All answers will be analyzed using frequencies and will be used in economical models to calculate productivity burden and societal and individual costs. | 3 months | |
Secondary | patient reported outcome measures (PROMS) productivity | iPCQ (Productivity Cost Questionnaire). All answers will be analyzed using frequencies and will be used in economical models to calculate productivity burden and societal and individual costs. | 3 months |
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