Antioxidant therapy in implementing lithotripsy in patients with renal lithiasis

Completed

Conditions: Kidney stone disease treated by extracorporeal shockwave lithotripsy
Urological and Genital Diseases
Calculus of kidney and ureter

Registration Number: ISRCTN98702137

Lead Sponsor: Reina Sofia Universitary Hospital (Spain)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 126

Inclusion Criteria

Patients > 18 yr with renal stones scheduled to be treated by extracorporeal shockwave lithotripsy

Exclusion Criteria

1. Any contraindication for lithotripsy.
2. Patients undergoing lithotripsy at the time of initiating the study
3. Severe impairment of treated kidney
4. Complications related to lithotripsy that need of an interventional procedure during the study period
5. Inability to understand or psychosocial maladjustment
6. Refusal to sign the informed consent form

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Renal vascular resistance index (ipsilateral and contralateral peripheric), measured by Doppler ultrasound of an interlobar artery branch at baseline, 24 hours and 10 days after lithotripsy.<br>2. Laboratory measurements, calculated from blood and urine samples taken at baseline, 2 hours before, 1 hour, 24 hours and 10 days after lithotripsy: <br>2.1. Lipoperoxides (MDA-4HA) (nmol/g)<br>2.2. Reduced Glutathione (GSH) (micromol/g)<br>2.3. Catalase<br>2.4. Superoxide dismutase<br>2.5. Gluthatione peroxidise<br>2.6. DNA damage (8OHdG)<br>2.7. Serum Nitric Oxide (NO) (nM/mL)<br>2.8. Renin (pg/ml)<br>2.8. Kallikrein<br>2.9. Serum aldosterone (ng/dl)<br>2.10. Endothelin-1 (pg/ml)<br>2.11. Urine Prostaglandin E2 (PGE2)<br>2.12. alpha Tumour Necrosis Factor (aTNF)<br>2.13. 1beta-Interleukin (IL)<br>2.14. 6-I

Secondary Outcome Measures

Name	Time	Method
Determination of glomerular filtration: <br>1. Cockroft-Gault<br>2. Modification of Diet in Renal Disease (MDRD)<br>3. Fractional excretion of sodium (mEq/l)<br>4. Corrected hyperglycemia Sodium (mEq/l)<br>5. Plasma osmolarity (mOsm/kg)<br>6. Blood Urea Nitrogen (BUN) (mg/100 ml)<br>7. B2 microglobulin (microg/min)<br>8. Albumin (g/l) in urine<br>9. Adrenomedullin<br>10. Lactate dehydrogenase (LDH) (units)<br>11. N-acetyl-D-glucosaminidase (NAG) (IU/l)<br>12. Alanine aminopeptidase (AAP) (IU/l)<br>13. Aspartate aminotransferase (AST)<br>14. Alanine aminotransferase (ALT)<br>15. Gammaglutamiltranspepsidasa (GGT)<br>16. Leucine aminopeptidase (LAP)<br>17. B-galactosidase