Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Francisco Jose Anglada


Contact details

Arroyo del Moro 6
+34 (0)60 7285666

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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


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.

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

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet.


Kidney stone disease treated by extracorporeal shockwave lithotripsy


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, 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.

Intervention type



Not Specified

Drug names

Alpha lipoic acid (ALA)

Primary outcome measure

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 measures

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

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

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

Participant type


Age group




Target number of participants

Target sample size of 126 patients, 63 in each group.

Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Arroyo del Moro 6

Sponsor information


Reina Sofia Universitary Hospital (Spain)

Sponsor details

Menendez Pidal sn
+34 (0)95 7011057

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Reina Sofia University Hospital (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes