Antioxidant therapy in implementing lithotripsy in patients with renal lithiasis

Randomised, prospective double-blind, placebo-controlled study to evaluate the effect of antioxidant therapy in preventing kidney damage caused by lithotripsy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN98702137

Enrollment

126

Registered

2010-03-10

Start date

2009-04-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

There are two arms, the treatment arm will receive alpha lipoic acid and the other one placebo. After being assigned by a randomisation program, obtained from the web page www.randomization.com, the

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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. 2. Laboratory measurements, calculated from blood and urine samples taken at baseline, 2 hours before, 1 hour, 24 hours and 10 days after lithotripsy: 2.1. Lipoperoxides (MDA-4HA) (nmol/g) 2.2. Reduced Glutathione (GSH) (micromol/g) 2.3. Catalase 2.4. Superoxide dismutase 2.5. Gluthatione peroxidise 2.6. DNA damage (8OHdG) 2.7. Serum Nitric Oxide (NO) (nM/mL) 2.8. Renin (pg/ml) 2.8. Kallikrein 2.9. Serum aldosterone (ng/dl) 2.10. Endothelin-1 (pg/ml) 2.11. Urine Prostaglandin E2 (PGE2) 2.12. alpha Tumour Necrosis Factor (aTNF) 2.13. 1beta-Interleukin (IL) 2.14. 6-IL	—

Measure

Time frame

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. 2. Laboratory measurements, calculated from blood and urine samples taken at baseline, 2 hours before, 1 hour, 24 hours and 10 days after lithotripsy: 2.1. Lipoperoxides (MDA-4HA) (nmol/g) 2.2. Reduced Glutathione (GSH) (micromol/g) 2.3. Catalase 2.4. Superoxide dismutase 2.5. Gluthatione peroxidise 2.6. DNA damage (8OHdG) 2.7. Serum Nitric Oxide (NO) (nM/mL) 2.8. Renin (pg/ml) 2.8. Kallikrein 2.9. Serum aldosterone (ng/dl) 2.10. Endothelin-1 (pg/ml) 2.11. Urine Prostaglandin E2 (PGE2) 2.12. alpha Tumour Necrosis Factor (aTNF) 2.13. 1beta-Interleukin (IL) 2.14. 6-IL

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Secondary

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

Measure

Time frame

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

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Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026