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| Name | Class |
|---|---|
| Salvador López Gil | UNKNOWN |
| Armando Vázquez Rangel | UNKNOWN |
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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)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allopurinol group | Active Comparator | The intervention group will receive 300 mg of allopurinol 12 hours before and 12 hours after the coronary intervention. |
|
| Placebo group | Placebo Comparator | The placebo group will receive 300 mg of placebo 12 hours before and 12 hours after the coronary intervention. |
|
| Febuxostat group | Active Comparator | The intervention group will receive 80 mg of febuxostat 12 hours before and 12 hours after the coronary intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allopurinol | Drug | Eligible patients will receive allopurinol 300 mg before and after coronary intervention |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Renal replacement therapy requirement | Initiation of renal replacement therapy | 7 days |
| Length of hospitalization | Length of hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magdalena Madero, MD | Contact | 01 52 55 5573 2911 | 21425 | madero.magdalena@gmail.com |
| Salvador Lopez-Gil, MD | Contact | 01 52 55 5573 2911 | 21425 | salvadorlgil@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Magdalena Madero, MD | Instituto Nacional de Cardiologia Ignacio Chavez | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Cardiologia Ignacio Chavez | Mexico City | México City | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28608311 | Background | 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. | |
| 25653965 |
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| ID | Term |
|---|---|
| D000493 | Allopurinol |
| D000069465 | Febuxostat |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Double blind clinical trial
| Febuxostat | Drug | Eligible patients will receive febuxostat 80 mg before and after coronary intervention |
|
|
| Placebo | Drug | Eligible patients will receive before and after coronary intervention |
|
| 3 days to 90 days |
| 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. |
| 27006404 | Background | 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. |
| 24942770 | Background | 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. |
| 25913922 | Background | 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. |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |