Effect of Allopurinol or Febuxostat to Prevent Contrast Induced Acute Kidney Injury (CI-AKI)

Study Overview
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Brief Summary
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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
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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

Official Title
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Effect of Allopurinol or Febuxostat to Prevent Contrast Induced Acute Kidney Injury (CI-AKI)

Conditions
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Contrast-induced Nephropathy, Contrast-induced Acute Kidney Injury

Intervention / Treatment
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* Drug: Allopurinol
* Drug: Febuxostat
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Allopurinol group<br>The intervention group will receive 300 mg of allopurinol 12 hours before and 12 hours after the coronary intervention. | Drug: Allopurinol<br>* Eligible patients will receive allopurinol 300 mg before and after coronary intervention<br>* Other names: Zyloprim;|
| Placebo Comparator: Placebo group<br>The placebo group will receive 300 mg of placebo 12 hours before and 12 hours after the coronary intervention. | Drug: Placebo<br>* Eligible patients will receive before and after coronary intervention<br>|
| Active Comparator: Febuxostat group<br>The intervention group will receive 80 mg of febuxostat 12 hours before and 12 hours after the coronary intervention | Drug: Febuxostat<br>* Eligible patients will receive febuxostat 80 mg before and after coronary intervention<br>* Other names: Turazive;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of contrast induced acute kidney injury | Increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal replacement therapy requirement | Initiation of renal replacement therapy | 7 days | 
| Length of hospitalization | Length of hospitalization | 3 days to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contrast induced acute kidney injury, contrast induced nephropathy, allopurinol, febuxostat