title: The Effect of Spironolactone on Acute Kidney Injury After Cardiac Surgery: A Randomized, Placebo-Controlled Trial.
abstract: BACKGROUND
  Cardiac surgery-related acute kidney injury (AKI) is a common postoperative complication that greatly increases morbidity and mortality. There are currently no effective interventions to prevent AKI associated with cardiac surgery. Experimental data have shown that administration of the mineralocorticoid receptor blocker spironolactone prevents renal injury induced by ischemia-reperfusion in rats. The objective of this study was to test whether short-term perioperative administration of oral spironolactone could reduce the incidence of AKI in cardiac surgical patients.
  
  
  METHODS
  Randomized, double-blinded, placebo-controlled trial.
  
  
  METHODS
  Data were collected from April 2014 through July 2015 at the National Heart Institute in Mexico. 233 patients were included; 115 and 118 received spironolactone or placebo, respectively.
  
  
  METHODS
  Spironolactone or placebo once at a dose of 100mg 12 to 24 hours before surgery and subsequently 3 further doses of 25mg in postoperative days 0, 1, and 2 were administered.
  
  
  RESULTS
  Patients were followed up for 7 days or until discharge from the intensive care unit (ICU). The primary end point was AKI incidence defined by KDIGO criteria. Secondary end points included requirement of renal replacement therapy, ICU length of stay, and ICU mortality. Data were analyzed according to the intention-to-treat principle.
  
  
  RESULTS
  Mean age was 53.2±15 years, mean serum creatinine level was 0.9±0.2mg/dL, median Thakar score for estimation of AKI risk was 2 (IQR, 1-3), and 25% had diabetes. The incidence of AKI was higher for the spironolactone group (43% vs 29%; P=0.02). No significant differences were found for secondary end points.
  
  
  CONCLUSIONS
  Single center, AKI was mostly driven by AKI stage 1, planned sample size was not achieved, and there was no renin-angiotensin-aldosterone system washout period.
  
  
  CONCLUSIONS
  Our trial demonstrated that spironolactone was not protective for AKI associated with cardiac surgery and there may be a trend toward risk.
authors: Departamento de Nefrología, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.
authors: Rubén
authors: R
authors: Barba-Navarro
authors: Departamento de Nefrología, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.
authors: Mirell
authors: M
authors: Tapia-Silva
authors: Departamento de Nefrología, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.
authors: Carlos
authors: C
authors: Garza-Garcia
authors: Departamento de Nefrología, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.
authors: Salvador
authors: S
authors: López-Giacoman
authors: Departamento de Nefrología, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.
authors: Ipsae
authors: I
authors: Melgoza-Toral
authors: Departamento de Nefrología, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.
authors: Armando
authors: A
authors: Vázquez-Rangel
authors: Departamento de Nefrología y Metabolismo Mineral, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; Molecular Physiology Unit, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico City, Mexico.
authors: Silvana
authors: S
authors: Bazúa-Valenti
authors: Departamento de Nefrología y Metabolismo Mineral, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; Molecular Physiology Unit, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico City, Mexico.
authors: Norma
authors: N
authors: Bobadilla
authors: Departamento de Nefrología, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.
authors: Michael
authors: M
authors: Wasung de Lay
authors: Departamento de Nefrología, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.
authors: Francisco
authors: F
authors: Baranda
authors: Division of Intensive Care Medicine and Nephrology, Department of Medicine, Veterans Affairs Medical Center, Washington, DC.
authors: Lakhmir S
authors: LS
authors: Chawla
authors: Departamento de Nefrología y Metabolismo Mineral, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; Molecular Physiology Unit, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Mexico City, Mexico. Electronic address: gamba@biomedicas.unam.mx.
authors: Gerardo
authors: G
authors: Gamba
authors: Departamento de Nefrología, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico. Electronic address: madero.magdalena@gmail.com.
authors: Magdalena
authors: M
authors: Madero
mesh_terms: D058186:Acute Kidney Injury / Q000209:etiology* / Q000517:prevention & control*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000209:etiology* / Q000517:prevention & control*; D013148:Spironolactone / Q000627:therapeutic use*
chemical_list: D000451:Mineralocorticoid Receptor Antagonists; D013148:Spironolactone
keywords: Acute kidney injury (AKI); cardiac surgery; cardiopulmonary bypass; mineralocorticoid receptor blocker; randomized controlled trial (RCT); renal ischemia; spironolactone