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

April 15, 2015 updated by: Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez

Pilot Non Randomised Controlled Trial of Short Term Spironolactone Use for Prevention of Acute Kidney Injury After Cardiac Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 14000
        • Not yet recruiting
        • Instituto Nacional de la Nutrición Salvador Zubirán
        • Contact:
        • Principal Investigator:
          • Gerardo Gamba, PhD
      • Mexico City, Distrito Federal, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Cardiologia Ignacio Chavez
        • Contact:
        • Contact:
        • Principal Investigator:
          • Magdalena Madero, M.D
        • Sub-Investigator:
          • Michael E Wasung, M.D
        • Sub-Investigator:
          • Salvador Lopez, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spironolactone
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.
Drug: Spironolactone
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.
Other Names:
  • Aldactone
  • Vivitar
No Intervention: No spironolactone
Cardiac surgical patients requiring cardiopulmonary bypass and aortic cross clamp, randomised not to receive spironolactone will be followed for 10 days after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
First 10 days after cardiac surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in urinary neutrophil gelatinase-associated lipocalin (NGAL) concentration.
Time Frame: 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.
First 10 days after cardiac surgery
Mortality
Time Frame: First 10 days after cardiac surgery
Mortality in patients submitted to cardiac surgery with or without previous spironolactone therapy.
First 10 days after cardiac surgery
Hyperkalemia
Time Frame: First 10 days after cardiac surgery
Hyperkalemia in patients submitted to cardiac surgery with or without previous spironolactone therapy.
First 10 days after cardiac surgery
Renal replacement therapy
Time Frame: First 10 days after cardiac surgery
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
Time Frame: 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.
First 20 days after cardiac surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Collaborators

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Investigators

  • Study Director: Gerardo Gamba, PhD, Instituto Nacional de la Nutrición Salvador Zubirán

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

April 15, 2015

First Posted (Estimate)

April 16, 2015

Study Record Updates

Last Update Posted (Estimate)

April 16, 2015

Last Update Submitted That Met QC Criteria

April 15, 2015

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPIRO-110313

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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