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

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ClinicalTrials.gov Identifier: NCT02417896
Recruitment Status : Unknown
Verified March 2013 by Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez.
Recruitment status was:  Recruiting
First Posted : April 16, 2015
Last Update Posted : April 16, 2015
Sponsor:
Collaborator:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Information provided by (Responsible Party):
Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez

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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injuries Kidney Injuries, Acute Kidney Injury, Acute Acute Renal Injury Acute Renal Injuries Drug: Spironolactone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Non Randomised Controlled Trial of Short Term Spironolactone Use for Prevention of Acute Kidney Injury After Cardiac Surgery
Study Start Date : April 2013
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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.



Primary Outcome Measures :
  1. 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 Measures :
  1. 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.

  2. Mortality [ Time Frame: First 10 days after cardiac surgery ]
    Mortality in patients submitted to cardiac surgery with or without previous spironolactone therapy.

  3. Hyperkalemia [ Time Frame: First 10 days after cardiac surgery ]
    Hyperkalemia in patients submitted to cardiac surgery with or without previous spironolactone therapy.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417896


Contacts
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Contact: Magdalena Madero, M.D. 55736902 madero.magdalena@gmail.com
Contact: Michael E Wasung, M.D. 52591788 mwasung@gmail.com

Locations
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Mexico
Instituto Nacional de la Nutrición Salvador Zubirán Not yet recruiting
Mexico City, Distrito Federal, Mexico, 14000
Contact: Gerardo Gamba, PhD    5255-55133868    gamba@biomedicas.unam.mx   
Principal Investigator: Gerardo Gamba, PhD         
Instituto Nacional de Cardiología Ignacio Chávez Recruiting
Mexico City, Distrito Federal, Mexico, 14080
Contact: Magdalena Madero, M.D    52555573 6902    madero.magdalena@gmail.com   
Contact: Michael E Wasung, M.D    52555573 2911 ext 1262    mwasung@gmail.com   
Principal Investigator: Magdalena Madero, M.D         
Sub-Investigator: Michael E Wasung, M.D         
Sub-Investigator: Salvador Lopez, M.D         
Sponsors and Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
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Study Director: Gerardo Gamba, PhD Instituto Nacional de la Nutrición Salvador Zubiran
Publications:

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Responsible Party: Magdalena Madero, M.D., Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier: NCT02417896    
Other Study ID Numbers: SPIRO-110313
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: March 2013
Keywords provided by Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez:
Acute kidney injury
Spironolactone
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents