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Short Term Spironolactone for Prevention of Acute Kidney Injury After Cardiac Surgery

Information source: Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Kidney Injuries; Kidney Injuries, Acute; Kidney Injury, Acute; Acute Renal Injury; Acute Renal Injuries

Intervention: Spironolactone (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Instituto Nacional de Cardiologia Ignacio Chavez

Official(s) and/or principal investigator(s):
Gerardo Gamba, PhD, Study Director, Affiliation: Instituto Nacional de la Nutrición Salvador Zubiran

Overall contact:
Magdalena Madero, M.D., Phone: 55736902, Email: madero.magdalena@gmail.com


Our aim is to test whether short term perioperative administration of oral spironolactone could reduce incidence of postoperative acute kidney injury (AKI) in cardiac surgical patients.

Clinical Details

Official title: Pilot Non Randomised Controlled Trial of Short Term Spironolactone Use for Prevention of Acute Kidney Injury After Cardiac Surgery

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Acute kidney injury (AKI) defined by the AKIN criteria in patients submitted to cardiac surgery with spironolactone therapy.

Secondary outcome:

Change in urinary neutrophil gelatinase-associated lipocalin (NGAL) concentration.



Renal replacement therapy

Length of stay in intensive care unit

Detailed description: Adult patients (>18 years old) were eligible for the study if they were undergoing elective or emergency cardiac surgery requiring CPB and aortic cross clamp. Exclusion criteria were patients with preoperative chronic renal insufficiency (Serum creatinine >1. 6 mg/dl) or on dialysis, hyperkalemia (>5. 0 mEq/L), AKI detected up to 24 hours before the procedure; patients receiving contrast agents 72 hours before surgery, planned off-pump cardiac surgery, hypersensitivity, allergy or known intolerance to spironolactone and pregnancy. Patients that died during the surgical procedure or 24 hours after surgery were eliminated from the analysis, as well as patients that did not receive spironolactone during the postoperative period. Criteria for stopping spironolactone were serum potassium >5. 5 mEq/L, a serum creatinine level ≥2. 5 mg/dL and urine output of <0. 3 ml/k/hr during 8 hours. One day prior to the procedure, patients that met the inclusion criteria were invited to participate in the trial, signing an informed consent. Spironolactone was administered orally by a study investigator (100 mg 12-24 hrs before surgery); subsequently three further doses of 25 mg were administered orally in postoperative days 1, 2 and 3. Thus, a total 1 x 100 mg and 3 x 25 mg doses of spironolactone in the intervention group were be given. If the patient had not been extubated, spironolactone was administered nasogastrically. Oral drugs were delayed by up to 4 hours if extubation had just occurred. The patients that decided not to receive spironolactone were followed during the study period and considered as controls. Preexisting ACE inhibitor, angiotensin receptor blocker, or MR antagonist were not suspended before surgery.


Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.


Inclusion Criteria:

- Informed consent

- Elective and emergent cardiac surgery with cardiopulmonary bypass and aortic cross

clamp Exclusion Criteria:

- Patients with preoperative chronic renal insufficiency on dialysis

- Acute kidney injury detected up to 24 hours before the procedure a

- Patients receiving contrast agents 72 hours before surgery

- Planned off-pump cardiac surgery

- Hypersensitivity, allergy or known intolerance to spironolactone

- Pregnancy

- Hyperkalemia with potassium >5. 0 mEq/L

Criteria for stopping study medication:

- Serum potassium >5. 5 mEq/L

Locations and Contacts

Magdalena Madero, M.D., Phone: 55736902, Email: madero.magdalena@gmail.com

Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Distrito Federal 14080, Mexico; Recruiting
Magdalena Madero, M.D, Phone: 52555573 6902, Email: madero.magdalena@gmail.com
Michael E Wasung, M.D, Phone: 52555573 2911, Ext: 1262, Email: mwasung@gmail.com
Magdalena Madero, M.D, Principal Investigator
Michael E Wasung, M.D, Sub-Investigator
Salvador Lopez, M.D, Sub-Investigator

Instituto Nacional de la Nutrición Salvador Zubirán, Mexico City, Distrito Federal 14000, Mexico; Not yet recruiting
Gerardo Gamba, PhD, Phone: 5255-55133868, Email: gamba@biomedicas.unam.mx
Gerardo Gamba, PhD, Principal Investigator

Additional Information

Related publications:

Barrera-Chimal J, Pérez-Villalva R, Rodríguez-Romo R, Reyna J, Uribe N, Gamba G, Bobadilla NA. Spironolactone prevents chronic kidney disease caused by ischemic acute kidney injury. Kidney Int. 2013 Jan;83(1):93-103. doi: 10.1038/ki.2012.352. Epub 2012 Sep 26.

Sánchez-Pozos K, Barrera-Chimal J, Garzón-Muvdi J, Pérez-Villalva R, Rodríguez-Romo R, Cruz C, Gamba G, Bobadilla NA. Recovery from ischemic acute kidney injury by spironolactone administration. Nephrol Dial Transplant. 2012 Aug;27(8):3160-9. doi: 10.1093/ndt/gfs014. Epub 2012 Apr 19.

Barrera-Chimal J, Pérez-Villalva R, Cortés-González C, Ojeda-Cervantes M, Gamba G, Morales-Buenrostro LE, Bobadilla NA. Hsp72 is an early and sensitive biomarker to detect acute kidney injury. EMBO Mol Med. 2011 Jan;3(1):5-20. doi: 10.1002/emmm.201000105. Epub 2010 Dec 14.

Prowle JR, Calzavacca P, Licari E, Ligabo EV, Echeverri JE, Haase M, Haase-Fielitz A, Bagshaw SM, Devarajan P, Bellomo R. Pilot double-blind, randomized controlled trial of short-term atorvastatin for prevention of acute kidney injury after cardiac surgery. Nephrology (Carlton). 2012 Mar;17(3):215-24. doi: 10.1111/j.1440-1797.2011.01546.x.

Pretorius M, Murray KT, Yu C, Byrne JG, Billings FT 4th, Petracek MR, Greelish JP, Hoff SJ, Ball SK, Mishra V, Body SC, Brown NJ. Angiotensin-converting enzyme inhibition or mineralocorticoid receptor blockade do not affect prevalence of atrial fibrillation in patients undergoing cardiac surgery. Crit Care Med. 2012 Oct;40(10):2805-12.

Starting date: April 2013
Last updated: April 15, 2015

Page last updated: August 23, 2015

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