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
Summary
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.Mortality Hyperkalemia 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
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
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