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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 April 2015
• Main ID: NCT02417896
• Date of registration: 13/04/2015
• Prospective Registration: No
• Primary sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
• Public title: Short Term Spironolactone for Prevention of Acute Kidney Injury After Cardiac Surgery
• Scientific title: Pilot Non Randomised Controlled Trial of Short Term Spironolactone Use for Prevention of Acute Kidney Injury After Cardiac Surgery
• Date of first enrolment: April 2013
• Target sample size: 150
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02417896
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

Mexico

Contacts

• Name: Gerardo Gamba, PhD
• Affiliation: Instituto Nacional de la Nutrición Salvador Zubiran

• Name: Magdalena Madero, M.D.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Kidney Injuries, Acute

Acute Renal Injury

Acute Renal Injuries

Acute Kidney Injuries

Kidney Injury, Acute

Intervention(s)

Drug: Spironolactone

Primary Outcome(s)

Acute kidney injury (AKI) defined by the AKIN criteria in patients submitted to cardiac surgery with spironolactone therapy. [Time Frame: First 10 days after cardiac surgery]

Secondary Outcome(s)

Hyperkalemia [Time Frame: First 10 days after cardiac surgery]

Change in urinary neutrophil gelatinase-associated lipocalin (NGAL) concentration. [Time Frame: First 10 days after cardiac surgery]

Length of stay in intensive care unit [Time Frame: First 20 days after cardiac surgery]

Renal replacement therapy [Time Frame: First 10 days after cardiac surgery]

Mortality [Time Frame: First 10 days after cardiac surgery]

Secondary ID(s)

SPIRO-110313

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran