Pharmacological modulation of the intrarenal pressure during endourological procedures in the upper urinary tract

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2008
INTERVENTION: Trade Name: isoprenalin Product Name: isoprenalin Product Code: 5115 Pharmaceutical Form: Concentrate for solution for infusion CAS Number: 5115 Current Sponsor code: 159500 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1‐ Pharmaceutical form of the placebo: Bladder irrigation Route of administration of the placebo: Urethral use CONDITION: Kidney stones Benignant conditions in the upper urinary tract PRIMARY OUTCOME: Main Objective: To lower the intrarenal pelvic pressure during retrograde intrarenal stone surgery by adding isoprenalin to the irrigation fluid during the operation Primary end point(s): Lowering of the renal pelvic pressure during ureropyeloscopy Secondary Objective: To shorten surgical time in retrograde intrarenal stone surgery whilst optimizing security and quality of the procedure. To spare the kidney parenchyma from high pressures. To measure intrarenal pressure in human during ureteroscopic procedures INCLUSION CRITERIA: Indication for ureteropyeloscopy, age> 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 97bd749c83e3b6a3781300f443edff594f2f6e35
First added on: Aug 21, 2024