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

National Institute of Cardiology Ignacio Chavez

Status: Unknown

Conditions: Kidney Injury, Acute; Acute Renal Injury; Kidney Injuries, Acute; Acute Kidney Injuries; Acute Renal Injuries

Treatments: Drug: Spironolactone

Study type: Interventional

Funder types: Other

Identifiers

NCT02417896

SPIRO-110313

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Spironolactone

Experimental group

Description:

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.

Treatment:

Drug: Spironolactone

No spironolactone

No Intervention group

Description:

Cardiac surgical patients requiring cardiopulmonary bypass and aortic cross clamp, randomised not to receive spironolactone will be followed for 10 days after surgery.