Acute Kidney Injuries, Acute Renal Injuries, Acute Renal Injury, Kidney Injuries, Acute, Kidney Injury, Acute
Conditions
Keywords
Acute kidney injury, Spironolactone
Brief 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.
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.
Interventions
DRUGSpironolactone
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.
Sponsors
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Instituto Nacional de Cardiologia Ignacio Chavez
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in urinary neutrophil gelatinase-associated lipocalin (NGAL) concentration. | First 10 days after cardiac surgery | Change in urinary neutrophil gelatinase-associated lipocalin (NGAL) concentration in patients submitted to cardiac surgery with or without previous spironolactone therapy. |
| Mortality | First 10 days after cardiac surgery | Mortality in patients submitted to cardiac surgery with or without previous spironolactone therapy. |
| Hyperkalemia | First 10 days after cardiac surgery | Hyperkalemia in patients submitted to cardiac surgery with or without previous spironolactone therapy. |
| Renal replacement therapy | First 10 days after cardiac surgery | Renal replacement therapy in patients submitted to cardiac surgery with or without previous spironolactone therapy. |
| Length of stay in intensive care unit | First 20 days after cardiac surgery | Length of stay in intensive care unit or patients submitted to cardiac surgery with or without previous spironolactone therapy. |
Countries
Mexico
Contacts
Primary ContactMagdalena Madero, M.D.
Backup ContactMichael E Wasung, M.D.
Outcome results
None listed