Antioxidant therapy in implementing lithotripsy in patients with renal lithiasis

ISRCTN	ISRCTN98702137
DOI	https://doi.org/10.1186/ISRCTN98702137
Secondary identifying numbers	N/A

Submission date: 14/02/2010
Registration date: 10/03/2010
Last edited: 10/03/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Francisco Jose Anglada
Scientific

Arroyo del Moro 6
Cordoba
14011
Spain

Phone	+34 (0)60 7285666
Email	ancusr@ono.com

Study information

Study design	Single centre interventional prospective double blind two arm randomised placebo controlled parallel group study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet.
Scientific title	Randomised, prospective double-blind, placebo-controlled study to evaluate the effect of antioxidant therapy in preventing kidney damage caused by lithotripsy
Study objectives	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(s)	Trial approved by Local Reina Sofia Hospital Clinical Trials Committee on February 25th, 2009 (acta: 168; ref: 1483)
Health condition(s) or problem(s) studied	Kidney stone disease treated by extracorporeal shockwave lithotripsy
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/04/2009
Completion date	01/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Target sample size of 126 patients, 63 in each group.
Key inclusion criteria	Patients > 18 yr with renal stones scheduled to be treated by extracorporeal shockwave lithotripsy
Key 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
Date of first enrolment	01/04/2009
Date of final enrolment	01/10/2010

Locations

Countries of recruitment

Spain

Study participating centre

Arroyo del Moro 6

Cordoba
14011
Spain

Sponsor information

Reina Sofia Universitary Hospital (Spain)
Hospital/treatment centre

Menendez Pidal sn
Cordoba
14005
Spain

Phone	+34 (0)95 7011057
Email	franciscoj.anglada.sspa@juntadeandalucia.es
Website	http://www.hospitalreinasofia.org
"ROR"	https://ror.org/02vtd2q19

Funders

Funder type

Hospital/treatment centre

Reina Sofia University Hospital (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan