Contact information
Type
Scientific
Primary contact
Dr Francisco Jose Anglada
ORCID ID
Contact details
Arroyo del Moro 6
Cordoba
14011
Spain
+34 (0)60 7285666
ancusr@ono.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
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
Acronym
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet.
Condition
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
Phase
Not Specified
Drug names
Alpha lipoic acid (ALA)
Primary outcome measures
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
01/04/2009
Overall trial end date
01/10/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Patients > 18 yr with renal stones scheduled to be treated by extracorporeal shockwave lithotripsy
Participant type
Patient
Age group
Adult
Gender
Both
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
01/04/2009
Recruitment end date
01/10/2010
Locations
Countries of recruitment
Spain
Trial participating centre
Arroyo del Moro 6
Cordoba
14011
Spain
Sponsor information
Organisation
Reina Sofia Universitary Hospital (Spain)
Sponsor details
Menendez Pidal sn
Cordoba
14005
Spain
+34 (0)95 7011057
franciscoj.anglada.sspa@juntadeandalucia.es
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Reina Sofia University Hospital (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Results - basic reporting
Publication summary