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Allopurinol Effect on MDA,NO,KIM-1 Urine Levels, RI and Renal Elastography in Kidney Stone Patients Post ESWL

NCT05414669 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-06-10

No results posted yet for this study

Summary

Extracorporeal shock wave lithotripsy (ESWL) is accepted as the first treatment choice for most urinary stones. Still, it has adverse effects on the kidneys. The mechanism underlying the shock wave induced renal injury is not entirely understood, and oxidative stress has been speculated to be involved in this process. The Investigator evaluated the role of allopurinol, which works as a xanthine oxidase inhibitor and free radical scavenger in renal protection against oxidative effects of ESWL. In a randomized, double-blind placebo-controlled trial, a total of 70 patients with renal stones undergoing ESWL were randomly assigned to 2 groups. Group 1 receive allopurinol, and group 2 receive a placebo. Allopurinol 300mg was given orally for a total of 3 days, beginning a day before ESWL. The urinary excretion of malondialdehyde (MDA), nitric oxide (NO), and kidney injury molecule-1 (KIM-1) were determined by quantitative double antibody sandwich direct ELISA at baseline before ESWL then repeatedly two h, and 24 h after ESWL. The resistive index (RI) change of the interlobar artery was asses along with the measurement of the shear wave velocity (SWV) in the focal zone of the treated kidney before, two weeks, and four weeks after ESWL. Multivariate analyses were performed using repeated measure ANOVA to control covariates.

Conditions

  • Kidney Calculi

Interventions

DRUG

Allopurinol Tablet 300 mg

Allopurinol 300mg was given orally for a total of 3 days, beginning a day before ESWL.

DRUG

Control Group

Placebo was given orally for a total of 3 days, beginning a day before ESWL.

Sponsors & Collaborators

  • Sanglah General Hospital

    lead OTHER

Principal Investigators

  • Kadek B Santosa, Urologist · Sanglah General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-06
Primary Completion
2021-03-01
Completion
2021-04-20

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05414669 on ClinicalTrials.gov