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| Name | Class |
|---|---|
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spironolactone | Experimental | The intervention group will receive spironolactone. The drug will be administered orally to cardiac surgical patients by a study investigator (100 mg 12-24 hrs before surgery); subsequently, three further doses of 25 mg are administered orally in the morning of postoperative days 1, 2 and 3. |
|
| No spironolactone | No Intervention | Cardiac surgical patients requiring cardiopulmonary bypass and aortic cross clamp, randomised not to receive spironolactone will be followed for 10 days after surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone | Drug | Spironolactone is administered orally to cardiac surgical patients by a study investigator (100 mg 12-24 hrs before surgery); subsequently three further doses of 25 mg are administered orally in the morning of postoperative days 1, 2 and 3. A total 1 x 100 mg and 3 x 25 mg doses of spironolactone in the intervention group will be given. If the patient has not been extubated, spironolactone is administered nasogastrically. Oral drugs will be delayed by up to 4 hours if extubation has just occurred. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute kidney injury (AKI) defined by the AKIN criteria in patients submitted to cardiac surgery with spironolactone therapy. | First 10 days after cardiac surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in urinary neutrophil gelatinase-associated lipocalin (NGAL) concentration. | Change in urinary neutrophil gelatinase-associated lipocalin (NGAL) concentration in patients submitted to cardiac surgery with or without previous spironolactone therapy. | First 10 days after cardiac surgery |
| Mortality |
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Inclusion Criteria:
Exclusion Criteria:
Criteria for stopping study medication:
- Serum potassium >5.5 mEq/L
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magdalena Madero, M.D. | Contact | 55736902 | madero.magdalena@gmail.com | |
| Michael E Wasung, M.D. | Contact | 52591788 | mwasung@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gerardo Gamba, PhD | Instituto Nacional de la NutriciĂłn Salvador Zubiran | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de la Nutrición Salvador Zubirán | Not yet recruiting | Mexico City | Mexico City | 14000 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23014458 | Background | Barrera-Chimal J, Perez-Villalva R, Rodriguez-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. | |
| 22516623 | Background | Sanchez-Pozos K, Barrera-Chimal J, Garzon-Muvdi J, Perez-Villalva R, Rodriguez-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. |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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|
|
Mortality in patients submitted to cardiac surgery with or without previous spironolactone therapy. |
| First 10 days after cardiac surgery |
| Hyperkalemia | Hyperkalemia in patients submitted to cardiac surgery with or without previous spironolactone therapy. | First 10 days after cardiac surgery |
| Renal replacement therapy | Renal replacement therapy in patients submitted to cardiac surgery with or without previous spironolactone therapy. | First 10 days after cardiac surgery |
| Length of stay in intensive care unit | Length of stay in intensive care unit or patients submitted to cardiac surgery with or without previous spironolactone therapy. | First 20 days after cardiac surgery |
| Instituto Nacional de CardiologĂa Ignacio Chávez | Recruiting | Mexico City | Mexico City | 14080 | Mexico |
|
| 21204265 | Background | Barrera-Chimal J, Perez-Villalva R, Cortes-Gonzalez 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. |
| 22117606 | Background | 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. |
| 22824930 | Background | 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. doi: 10.1097/CCM.0b013e31825b8be2. |
| 39878152 | Derived | Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |