Condition category
Urological and Genital Diseases
Date applied
14/02/2010
Date assigned
10/03/2010
Last edited
10/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.hospitalreinasofia.org

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

Publication citations

Additional files

Editorial Notes