Renal Insufficiency Clinical Trial
Official title:
The Effect of Three Endourological Procedures for the Management of Renal Calculi Regarding Acute Kidney Injury: a Prospective Randomized 3-arm Study.
NCT number | NCT03112499 |
Other study ID # | 1343/2017 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 5, 2018 |
Est. completion date | June 15, 2021 |
Verified date | May 2022 |
Source | Institute for the Study of Urological Diseases, Greece |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main aim of the study is to investigate and compare the possible acute effect of standard PCNL, mini-PCNL and RIRS on renal function. Secondary aims are to investigate the efficacy (stone-free rate), safety (complication rate, long-term kidney function) and other parameters (operation, fluoroscopy and hospitalization time) concerning the 3 endourological operations (PCNL, mini- PCNL, RIRS) for the treatment of renal calculi.
Status | Completed |
Enrollment | 75 |
Est. completion date | June 15, 2021 |
Est. primary completion date | March 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patients aged > 18 years old 2. Patients with renal stone or stones of 10-30 mm in maximal diameter measured in computed tomography scan. 3. Decision of the patient to receive surgical treatment 4. Ability to understand and provide a written informed consent to participate in the study. Exclusion Criteria: 1. Solitary kidney (functional or organic) 2. Ureteral stone in the same system causing obstruction 3. Malignant tumor in the treated kidney 4. Stone in diverticulum 5. Diabetes or coronary heart disease. 6. History of surgery in the treated kidney 7. Recent intake of drugs that affect renal function or intravenous contrast agent 8. Concomitant urinary infection 9. Congenital anomalies of the urinary tract 10. Patients of whom incomplete clinical data or incomplete samples are available |
Country | Name | City | State |
---|---|---|---|
Greece | G.Gennimatas Hospital | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Institute for the Study of Urological Diseases, Greece |
Greece,
Balasar M, Piskin MM, Topcu C, Demir LS, Gürbilek M, Kandemir A, Öztürk A. Urinary kidney injury molecule-1 levels in renal stone patients. World J Urol. 2016 Sep;34(9):1311-6. doi: 10.1007/s00345-016-1765-y. Epub 2016 Jan 21. — View Citation
Daggülli M, Utangaç MM, Dede O, Bodakci MN, Hatipoglu NK, Penbegül N, Sancaktutar AA, Bozkurt Y, Söylemez H. Potential biomarkers for the early detection of acute kidney injury after percutaneous nephrolithotripsy. Ren Fail. 2016;38(1):151-6. doi: 10.3109/0886022X.2015.1073494. Epub 2015 Oct 19. — View Citation
Dede O, Dagguli M, Utangaç M, Yuksel H, Bodakci MN, Hatipoglu NK, Sancaktutar AA, Penbegül N. Urinary expression of acute kidney injury biomarkers in patients after RIRS: it is a prospective, controlled study. Int J Clin Exp Med. 2015 May 15;8(5):8147-52. eCollection 2015. — View Citation
Haase M, Bellomo R, Devarajan P, Schlattmann P, Haase-Fielitz A; NGAL Meta-analysis Investigator Group. Accuracy of neutrophil gelatinase-associated lipocalin (NGAL) in diagnosis and prognosis in acute kidney injury: a systematic review and meta-analysis. Am J Kidney Dis. 2009 Dec;54(6):1012-24. doi: 10.1053/j.ajkd.2009.07.020. Epub 2009 Oct 21. Review. — View Citation
Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. — View Citation
Lin X, Yuan J, Zhao Y, Zha Y. Urine interleukin-18 in prediction of acute kidney injury: a systemic review and meta-analysis. J Nephrol. 2015 Feb;28(1):7-16. doi: 10.1007/s40620-014-0113-9. Epub 2014 Jun 5. Review. — View Citation
Vaidya VS, Waikar SS, Ferguson MA, Collings FB, Sunderland K, Gioules C, Bradwin G, Matsouaka R, Betensky RA, Curhan GC, Bonventre JV. Urinary biomarkers for sensitive and specific detection of acute kidney injury in humans. Clin Transl Sci. 2008 Dec;1(3):200-8. doi: 10.1111/j.1752-8062.2008.00053.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change in urine NGAL/Cr value | Urine NGAL/Cr value in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique will be measured using Elisa technique. | 2 hours preoperative and 2 hours postoperatively | |
Secondary | The change in urine NGAL/Cr value | Urine NGAL/Cr value in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique will be measured using Elisa technique. | 2 hours preoperative and 6, 24, 48 hours postoperatively | |
Secondary | The change in urine KIM-1/Cr value | Urine KIM-1/Cr value in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique will be measured using Elisa technique. | 2 hours preoperative and 2, 6, 24, 48 hours postoperatively | |
Secondary | The change in urine IL-18/Cr value | Urine IL-18/Cr value in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique will be measured using Elisa technique. | 2 hours preoperative and 2, 6, 24, 48 hours postoperatively | |
Secondary | The difference in the values of urine NGAL/Cr, KIM1/Cr and IL-18/Cr between the patients undergone nephrolithotripsy with standard PCNL and those undergone nephrolithotripsy with mini - PCNL technique | Urine NGAL/Cr, KIM1/Cr and IL-18/Cr values in all patients undergone nephrolithotripsy with standard PCNL or mini-PCNL technique will be measured using Elisa technique. | 2, 6, 24, 48 hours postoperatively | |
Secondary | The difference in the values of urine NGAL/Cr, KIM1/Cr and IL-18/Cr between the patients undergone nephrolithotripsy with standard PCNL and those undergone nephrolithotripsy with RIRS technique | Urine NGAL/Cr, KIM1/Cr and IL-18/Cr values in all patients undergone nephrolithotripsy with standard PCNL or RIRS technique will be measured using Elisa technique. | 2, 6, 24, 48 hours postoperatively | |
Secondary | The difference in the values of urine NGAL/Cr, KIM1/Cr and IL-18/Cr between the patients undergone nephrolithotripsy with mini -PCNL and those undergone nephrolithotripsy with RIRS technique | Urine NGAL/Cr, KIM1/Cr and IL-18/Cr values in all patients undergone nephrolithotripsy with mini-PCNL or RIRS technique will be measured using Elisa technique. | 2, 6, 24, 48 hours postoperatively | |
Secondary | The presence of Acute Kidney Injury(AKI) in patients undergoing PCNL, mini-PCNL or RIRS | Potential presence of AKI in patients undergoing PCNL or mini-PCNL or RIRS for the treatment of renal stones of 10-30mm in maximal diameter according to the KDIGO criteria, defined as: Serum Cr rise of 0,3mg/dl (=26µmol/L) within 48 hours or 50-99% Cr rise from baseline within 7 days (1, 50-1, 99 x baseline) or urine output <0, 5/kg/h for more than 6 hours | from the time of operation until 48 hours postoperatively | |
Secondary | The change in serum creatinine and eGFR values postoperatively in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique. | Serum creatinine levels will be measured using autoanalyzer
Calculation of eGFR will be done according to the equation CKD-EPI: GFR = 141 * min(Scr/?,1)a * max(Scr/?, 1)-1.209 * 0.993Age * 1.018 [if female] * 1.159 [if black] *Scr is serum creatinine (mg/dL), ? is 0.7 for females and 0.9 for males, a is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/? or 1, and max indicates the maximum of Scr/? or 1 |
1 month and 3 months postoperatively | |
Secondary | Percent of patients achieving treatment success and stone-free state in after undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique. | Treatments success (considered as absence of any stone or presence of residual stone fragment 4mm)
Stone-free rate (considered as absence of any stone) in CT scan |
4 weeks postoperatively | |
Secondary | Overall complications rates in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique. | Complications will be recorded according the Clavien Dindo grading system | from the time of operation until the 3 month follow up visit | |
Secondary | Operation time in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique. | Operation time will be recorded in minutes | - from the renal puncture until the placement of the renal tube in the end of the PCNL or mini-PCNL operations/- From the insertion of the resectoscope into the bladder until the placement of the urethra catheter in the end of the RIRS operation | |
Secondary | Fluoroscopy time in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique. | Fluoroscopy time will be recorded in minutes automatically by the fluoroscopic machine | from the renal puncture until the placement of the renal tube in the end of the PCNL or mini-PCNL operations/- From the insertion of the resectoscope into the bladder until the placement of the urethra catheter in the end of the RIRS operation | |
Secondary | Hospital stay duration in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique. | Hospitalization time will be recorded in days | From the day of operation until the day of discharge, up to 7 days | |
Secondary | Postoperative pain, in all patients undergone nephrolithotripsy with PCNL, mini-PCNL or RIRS technique. | Postoperative pain will be measured by a visual analog scale (VAS) pain score | Immediately after the operation and in 2, 6, 24, 48 hours postoperatively. |
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