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11 February 2012
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| [ Print-friendly version ] |
| Antioxidant therapy in implementing lithotripsy in patients with renal lithiasis |
| ISRCTN | ISRCTN98702137 |
| ClinicalTrials.gov identifier | |
| Public title | Antioxidant therapy in implementing lithotripsy in patients with renal lithiasis |
| Scientific title | Randomised, prospective double-blind, placebo-controlled study to evaluate the effect of antioxidant therapy in preventing kidney damage caused by lithotripsy |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis |
The initial treatment in most cases of urolithiasis is actually the application of extracorporeal shockwave lithotripsy. However, pressure waves cause damage to the renal parenchyma. The mechanism of tissue damage is not well known. The collapse of cavitation bubbles generated by the waves may be responsible of the cellular changes, facilitated by the formation of small collections after the rupture of microvessels. There are underlying hormonal vasoactive inflammatory phenomena. The final common mediator lies in oxidative imbalance, with increased lipid peroxidation and decrease of cellular antioxidant capacity.
The aim of the trial is to assess if the association of a drug with a potent antioxidant effect, alpha lipoic acid (ALA), avoids or diminishes the renal injury caused by lithotripsy. Secondary objectives are: 1. Evaluate changes in markers of renal damage and function after application of the shockwaves. 2. Determine the status of parameters of oxidative stress markers and antioxidant defenses and any changes after treatment with lithotripsy. 3. Assess the state of vasoactive hormones involved in pathogenesis of renal injury associated with kidney stones, and the application of lithotripsy. 4. Analyze the impact of the administration of ALA in parameters of oxidative stress parameters, hormonal and renal damage. |
| Lay summary | |
| Ethics approval | Trial approved by Local Reina Sofia Hospital Clinical Trials Committee on February 25th, 2009 (acta: 168; ref: 1483) |
| Study design | Single centre interventional prospective double blind two arm randomised placebo controlled parallel group study |
| Countries of recruitment | Spain |
| Disease/condition/study domain | Kidney stone disease treated by extracorporeal shockwave lithotripsy |
| Participants - inclusion criteria | Patients > 18 yr with renal stones scheduled to be treated by extracorporeal shockwave lithotripsy |
| Participants - 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 |
| Anticipated start date | 01/04/2009 |
| Anticipated end date | 01/10/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use contact details below to request a patient information sheet. |
| Target number of participants | Target sample size of 126 patients, 63 in each group. |
| 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 patients included in the treatment arm will receive ALA (400 mg/day), those assigned to the placebo arm will receive a placebo of identical dosage and appearance. Both drug and placebo will be presented in oral pills, distributed in two jars, containing a week of pills in each. Patients will take one pill twice daily for a total of two weeks. The total duration of the follow-up period is two weeks. |
| Primary outcome measure(s) |
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 (αTNF) 2.13. 1beta-Interleukin (IL) 2.14. 6-IL |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Reina Sofia University Hospital (Spain) |
| Trial website | |
| Publications | |
| Contact name | Dr Francisco Jose Anglada |
| Address | Arroyo del Moro 6 |
| City/town | Cordoba |
| Zip/Postcode | 14011 |
| Country | Spain |
| Tel | +34 (0)60 7285666 |
| ancusr@ono.com | |
| Sponsor | Reina Sofia Universitary Hospital (Spain) |
| Address | Menendez Pidal sn |
| City/town | Cordoba |
| Zip/Postcode | 14005 |
| Country | Spain |
| Tel | +34 (0)95 7011057 |
| Fax | +34 (0)95 7011059 |
| franciscoj.anglada.sspa@juntadeandalucia.es | |
| Sponsor website: | http://www.hospitalreinasofia.org |
| Date applied | 14/02/2010 |
| Last edited | 10/03/2010 |
| Date ISRCTN assigned | 10/03/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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