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

Alhasan Mujtaba, Mohammed A Taher, Mazin A Hazza, Hassan M Al-Rubaye, Asaad H Kata, Hamid AbdulWahab, AbdulAmeer AbdulBari, Hayder K AlRubay, Alhasan Mujtaba, Mohammed A Taher, Mazin A Hazza, Hassan M Al-Rubaye, Asaad H Kata, Hamid AbdulWahab, AbdulAmeer AbdulBari, Hayder K AlRubay

Abstract

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.

Keywords: Acute kidney injury (AKI); Aldactone; Angiography; Angioplasty; Contrast-induced nephropathy (CIN); Ischemic heart disease (IHD); Percutaneous coronary angiography (PCI); Spironolactone.

Figures

Fig. 1
Fig. 1
Study flow diagram. NGAL neutrophil gelatinase-associated lipocalin, S.K+ serum potassium, S.Cr. serum creatinine

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