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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control arm | Other | This arm is consisted of 60 patients.They will receive IV hydration and N-acetylcysteine (control arm). |
|
| Febuxostat arm | Experimental | This arm is consisted of 60 patients.They will receive IV hydration, N-acetylcysteine and Febuxostat . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isotonic saline | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| prevention of CI-AKI | incidence of CI-AKI after 48-72 hours after PCI | 48-72 hours post contrast |
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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 .
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| Name | Affiliation | Role |
|---|---|---|
| Rania Saad, Bachelor | Faculty of medicine Ain shams university | Principal Investigator |
| Iman Sarhan, PhD | Faculty of medicine Ain Shams university | Study Director |
| Nahla Teama, PhD | Faculty of medicine Ain Shams university | Study Chair |
| Yasser Alaa, PhD | Faculty of medicine Ain Shams university | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university hospitals | Cairo | 1181 | Egypt |
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| N-acetyl cysteine | Drug | 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 . |
|
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| Febuxostat 80 MG | Drug | 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. |
|
|
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000111 | Acetylcysteine |
| D000069465 | Febuxostat |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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