Urolithiasis Clinical Trial
Official title:
Effect of Use of Ureteral Access Sheath on Blood and Urine Levels of Netrin-1 in Patients Undergoing Retrograde Intrarenal Surgery
In this study, it is aimed to evaluate whether use of a ureteral access sheath (UAS) during retrograde intrarenal surgery (RIRS) due to kidney stone has any effect on protecting the kidney functions by measuring blood and urine and Netrin-1 levels.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | July 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Being between 18-65 years old - Having an indication of retrograde infrarenal surgery (RIRS) due to kidney stone Exclusion Criteria: - Patients with uncontrolled diabetes mellitus and diabetic nephropathy - Patients with blood pressure > 140/80 mmHg despite regular use of antihypertensive agent(s) - Patients with chronic kidney failure who need dialysis - Patients who have had prerenal, renal or postrenal acute kidney failure 3 months or much earlier - Patients who have had pyelonephritis 3 months or much earlier - Patients younger than 18 years or older than 65 years - Patients who have undergone a kidney surgery within the last 3 months and have abnormal kidney function tests - Patients with a concomitant ureter stone who will undergo an endoscopic ureter stone treatment at the same session |
Country | Name | City | State |
---|---|---|---|
Turkey | Selcuk University, School of Medicine, Department of Urology | Konya |
Lead Sponsor | Collaborator |
---|---|
Selcuk University | The Scientific and Technological Research Council of Turkey |
Turkey,
Aboumarzouk OM, Monga M, Kata SG, Traxer O, Somani BK. Flexible ureteroscopy and laser lithotripsy for stones >2 cm: a systematic review and meta-analysis. J Endourol. 2012 Oct;26(10):1257-63. doi: 10.1089/end.2012.0217. Review. — View Citation
Auge BK, Pietrow PK, Lallas CD, Raj GV, Santa-Cruz RW, Preminger GM. Ureteral access sheath provides protection against elevated renal pressures during routine flexible ureteroscopic stone manipulation. J Endourol. 2004 Feb;18(1):33-6. — View Citation
Barallobre MJ, Pascual M, Del Río JA, Soriano E. The Netrin family of guidance factors: emphasis on Netrin-1 signalling. Brain Res Brain Res Rev. 2005 Jul;49(1):22-47. Review. — View Citation
Cepeda M, Amón JH, Mainez JA, Rodríguez V, Alonso D, Martínez-Sagarra JM. Flexible ureteroscopy for renal stones. Actas Urol Esp. 2014 Nov;38(9):571-5. doi: 10.1016/j.acuro.2014.03.014. English, Spanish. — View Citation
Delanaye P, Cavalier E, Morel J, Mehdi M, Maillard N, Claisse G, Lambermont B, Dubois BE, Damas P, Krzesinski JM, Lautrette A, Mariat C. Detection of decreased glomerular filtration rate in intensive care units: serum cystatin C versus serum creatinine. BMC Nephrol. 2014 Jan 13;15:9. doi: 10.1186/1471-2369-15-9. — View Citation
Kourambas J, Byrne RR, Preminger GM. Does a ureteral access sheath facilitate ureteroscopy? J Urol. 2001 Mar;165(3):789-93. — View Citation
L'esperance JO, Ekeruo WO, Scales CD Jr, Marguet CG, Springhart WP, Maloney ME, Albala DM, Preminger GM. Effect of ureteral access sheath on stone-free rates in patients undergoing ureteroscopic management of renal calculi. Urology. 2005 Aug;66(2):252-5. — View Citation
Oguz U, Resorlu B, Ozyuvali E, Bozkurt OF, Senocak C, Unsal A. Categorizing intraoperative complications of retrograde intrarenal surgery. Urol Int. 2014;92(2):164-8. doi: 10.1159/000354623. — View Citation
Ramesh G, Krawczeski CD, Woo JG, Wang Y, Devarajan P. Urinary netrin-1 is an early predictive biomarker of acute kidney injury after cardiac surgery. Clin J Am Soc Nephrol. 2010 Mar;5(3):395-401. doi: 10.2215/CJN.05140709. — View Citation
Shlipak MG, Mattes MD, Peralta CA. Update on cystatin C: incorporation into clinical practice. Am J Kidney Dis. 2013 Sep;62(3):595-603. doi: 10.1053/j.ajkd.2013.03.027. Review. — View Citation
Stern JM, Yiee J, Park S. Safety and efficacy of ureteral access sheaths. J Endourol. 2007 Feb;21(2):119-23. Review. — View Citation
Traxer O, Wendt-Nordahl G, Sodha H, Rassweiler J, Meretyk S, Tefekli A, Coz F, de la Rosette JJ. Differences in renal stone treatment and outcomes for patients treated either with or without the support of a ureteral access sheath: The Clinical Research Office of the Endourological Society Ureteroscopy Global Study. World J Urol. 2015 Dec;33(12):2137-44. doi: 10.1007/s00345-015-1582-8. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood Netrin-1 level (pg/mL) | Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring blood Netrin-1 level. | Within the first 48 hours after the surgery (RIRS) | |
Secondary | Urine Netrin-1 level (pg/mL) | Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring urine Netrin-1 level. | Within the first 24 hours after the surgery (RIRS) | |
Secondary | Blood urea level (mg/dL) | Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring blood urea levels. | Within the first 7 days after surgery (RIRS) | |
Secondary | Blood creatinine level (mg/dL) | Determination of any impairment in renal function when ureteral access sheath is not used during RIRS by measuring blood creatinine levels. | Within the first 7 days after surgery (RIRS) |
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