The Effect of Spironolactone on the Incidence of Contrast-Induced Nephropathy in Patients Undergoing Cardiac Catheterization: Study Design and Rationale

• Published in: Cardiology and therapy 2018-06, Vol.7 (1), p.101-106
• Main Authors: Mujtaba, Alhasan, Taher, Mohammed A., Hazza, Mazin A., Al-Rubaye, Hassan M., Kata, Asaad H., AbdulWahab, Hamid, AbdulBari, AbdulAmeer, AlRubay, Hayder K.
• Format: Article
• Language: English
• Subjects: Cardiac catheterization; Cardiology; Internal Medicine; Intubation; Medicine; Medicine & Public Health; Study Protocol
• ISSN: 2193-8261; 2193-6544
• DOI: 10.1007/s40119-018-0112-3

Introduction Patients undergoing coronary catheterization are at high risk of developing contrast-induced nephropathy (CIN) acute kidney injury (AKI). Several approaches have been supposed to limit such an effect but with mixed results or non-practical methods. Spironolactone is supposed to be effective as a nephroprotective agent in animal studies. This study will try to measure the effect of spironolactone on the incidence of CIN-AKI in patients undergoing coronary catheterization (angiography angioplasty). Methods This study is a single-center, investigator-driven, double-blinded randomized controlled study in Iraq-Basra. More than 400 patients admitted for coronary angio unit in our center will be allocated in a 1:1 ratio to receive either spironolactone 200 mg single dose or placebo in addition to their usual premedication. Planned Outcomes Primary end point will be CIN defined as more than 25% or 0.3 mg/dl elevation in serum creatinine (S.Cr.) from baseline during the first 2–3 days after the procedure. We hope to identify or answer an important question regarding CIN in such high-risk patients. Trial Registration ClinicalTrials.gov Identifier, NCT03329443.