Renoprotective Effect of Febuxostat on Contrast Induced Acute Kidney Injury in Chronic Kidney Disease Patients Stage 3

Study Overview
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Brief Summary
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This study will determine the renoprotective effect of febuxostat in prevention of contrast induced acute kidney injury in chronic kidney disease patients Stage 3 undergoing percutaneous coronary intervention.

Detailed Description
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In this randomised non blinded clinical trial, Investigators will study 120 CKD patients undergoing PCI to determine the renoprotective effect of febuxostat in prevention of contrast induced acute kidney injury . So, the patients will be divided into two arms based on block randomization. Each arm compromise 60 patients. The first arm will receive IV hydration and N-acetylcysteine (ctrl arm) . The second arm will receive IV hydration, N-acetylcysteine and Febuxostat (F arm). Block randomization will be used in this clinical trial design to reduce bias and achieve balance in the allocation of participants to treatment arms.

Official Title
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Renoprotective Effect of Febuxostat on Contrast Induced Acute Kidney Injury in Chronic Kidney Disease Patients Stage 3

Conditions
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Chronic Kidney Disease stage3, Contrast-induced Nephropathy

Intervention / Treatment
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* Drug: Isotonic saline
* Drug: N-acetyl cysteine
* Drug: Febuxostat 80 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old . Patients under treatment of high dose statin(Atorvastatin (40-80 mg/day) . Glomerular filtration rate=30-59ml/min. Undergoing coronary PCI. Exclusion Criteria: Patients under treatment with febuxostat. Known allergy to febuxostat. High osmolar contrast media during the procedure .
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: control arm<br>This arm is consisted of 60 patients.They will receive IV hydration and N-acetylcysteine (control arm). | Drug: Isotonic saline<br>* All patients will receive a continuous intravenous infusion of isotonic saline at a rate of 0.5 mL/kg/h for at least 2 to 12 hours before the procedure and continued to receive it 6 to 24 hours afterward.<br>* Other names: Saline;Drug: N-acetyl cysteine<br>* all the patients will receive 600 mg orally twice daily ,on the day before and the day of exposure to contrast or a single periprocedural dose (within 4 hours of contrast exposure) 1200 mg .<br>* Other names: NAC;|
| Experimental: Febuxostat arm<br>This arm is consisted of 60 patients.They will receive IV hydration, N-acetylcysteine and Febuxostat . | Drug: Isotonic saline<br>* All patients will receive a continuous intravenous infusion of isotonic saline at a rate of 0.5 mL/kg/h for at least 2 to 12 hours before the procedure and continued to receive it 6 to 24 hours afterward.<br>* Other names: Saline;Drug: N-acetyl cysteine<br>* all the patients will receive 600 mg orally twice daily ,on the day before and the day of exposure to contrast or a single periprocedural dose (within 4 hours of contrast exposure) 1200 mg .<br>* Other names: NAC;Drug: Febuxostat 80 MG<br>* All patients will receive a continuous intravenous infusion of isotonic saline at a rate of 0.5 mL/kg/h for at least 2 to 12 hours before the procedure and continued to receive it 6 to 24 hours afterward.<br>* Other names: Feburic 80;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevention of CI-AKI | incidence of CI-AKI after 48-72 hours after PCI | 48-72 hours post contrast |