Clinical trial NCT03767322: Effect of Allopurinol or Febuxostat to Prevent Contrast Induced Acute Kidney Injury (CI-AKI)
Official title: Effect of Allopurinol or Febuxostat to Prevent Contrast Induced Acute Kidney Injury (CI-AKI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Contrast-induced Nephropathy
Contrast-induced Acute Kidney Injury
Keywords: contrast induced acute kidney injury
contrast induced nephropathy
allopurinol
febuxostat
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
Collaborators: name: Salvador López Gil
name: Armando Vázquez Rangel
First posted: 2018-12-06
Enrollment: 558
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized, placebo-controlled, double-blind clinical trial of effect of allopurinol or febuxostat to prevent contrast induced acute kidney injury (CI-AKI)

Detailed description: Eligible patients (patients with glomerular filtration rate \< 60 ml/min or high riks patients based on Mehran score) that will be undergoing cardiac catheterization/intervention randomly assigned to receive allopurinol 300 mg or febuxostat 80 mg 12 hours before and 12 after 1 exposure of radiocontrast and IV hydration (normal saline 1 ml/kg/hr 12 pre and post radiocontrast exposure) or placebo and hydration.

Exclusion criteria: patients under treatment with allopurinol or febuxostat in the previous seven days, known allergy to allopurinol or febuxostat, patients on renal replacement therapy

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older who are scheduled to coronary intervention
* Patients with Mehran score \> 5 or modified Mehran score \>2 even glomerular filtration rate \> 60 ml/min (high risk patients)
* Glomerular Filtration Rate \< 60 ml/min
* All the patients provided written informed consent for the procedures and the test drug

Exclusion Criteria:

* Patients with shorter hospital stay (\<48 hours)
* Patients under treatment with allopurinol of febuxostat
* Patients on renal replacement therapy
* Known allergy to allopurinol or febuxostat

Primary outcomes:
measure: Prevention of contrast induced acute kidney injury
timeFrame: 48 hours
Secondary outcomes:
measure: Renal replacement therapy requirement
timeFrame: 7 days
measure: Length of hospitalization
timeFrame: 3 days to 90 days
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cardiologia Ignacio Chavez
state: México City
Study officials:
affiliation: Instituto Nacional de Cardiologia Ignacio Chavez
name: Magdalena Madero, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghelich Khan Z, Talasaz AH, Pourhosseini H, Hosseini K, Alemzadeh Ansari MJ, Jalali A. Potential Role of Allopurinol in Preventing Contrast-Induced Nephropathy in Patients Undergoing Percutaneous Coronary Intervention: A Randomized Placebo-Controlled Trial. Clin Drug Investig. 2017 Sep;37(9):853-860. doi: 10.1007/s40261-017-0542-z.
citation: Kumar A, Bhawani G, Kumari N, Murthy KS, Lalwani V, Raju ChN. Comparative study of renal protective effects of allopurinol and N-acetyl-cysteine on contrast induced nephropathy in patients undergoing cardiac catheterization. J Clin Diagn Res. 2014 Dec;8(12):HC03-7. doi: 10.7860/JCDR/2014/9638.5255. Epub 2014 Dec 5.
citation: Mendi MA, Afsar B, Oksuz F, Turak O, Yayla C, Ozcan F, Johnson RJ, Kanbay M. Uric Acid is a Useful Tool to Predict Contrast-Induced Nephropathy. Angiology. 2017 Aug;68(7):627-632. doi: 10.1177/0003319716639187. Epub 2016 Mar 22.
citation: Shibagaki Y, Ohno I, Hosoya T, Kimura K. Safety, efficacy and renal effect of febuxostat in patients with moderate-to-severe kidney dysfunction. Hypertens Res. 2014 Oct;37(10):919-25. doi: 10.1038/hr.2014.107. Epub 2014 Jun 19.
citation: Fukui T, Maruyama M, Yamauchi K, Yoshitaka S, Yasuda T, Abe Y. Effects of Febuxostat on Oxidative Stress. Clin Ther. 2015 Jul 1;37(7):1396-401. doi: 10.1016/j.clinthera.2015.03.026. Epub 2015 Apr 23.