NCT02417896

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

April 16, 2015

Status Verified

March 1, 2013

Enrollment Period

2.2 years

First QC Date

April 13, 2015

Last Update Submit

April 15, 2015

Conditions

Acute Kidney InjuriesKidney Injuries, AcuteKidney Injury, AcuteAcute Renal InjuryAcute Renal Injuries

Keywords

Acute kidney injurySpironolactone

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in urinary neutrophil gelatinase-associated lipocalin (NGAL) concentration.

    First 10 days after cardiac surgery

  • Mortality

    First 10 days after cardiac surgery

  • Hyperkalemia

    First 10 days after cardiac surgery

  • Renal replacement therapy

    First 10 days after cardiac surgery

  • Length of stay in intensive care unit

    First 20 days after cardiac surgery

Study Arms (2)

Spironolactone

EXPERIMENTAL

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

No spironolactone

NO INTERVENTION

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

Interventions

SpironolactoneDRUG

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.

Also known as: Aldactone, Vivitar
Spironolactone

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent
  • Elective and emergent cardiac surgery with cardiopulmonary bypass and aortic cross clamp

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instituto Nacional de la Nutrición Salvador Zubirán

Mexico City, Mexico City, 14000, Mexico

NOT YET RECRUITING

Instituto Nacional de Cardiología Ignacio Chávez

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Related Publications (6)

  • Barrera-Chimal J, Perez-Villalva R, Rodriguez-Romo R, Reyna J, Uribe N, Gamba G, Bobadilla NA. Spironolactone prevents chronic kidney disease caused by ischemic acute kidney injury. Kidney Int. 2013 Jan;83(1):93-103. doi: 10.1038/ki.2012.352. Epub 2012 Sep 26.

    PMID: 23014458BACKGROUND

  • Sanchez-Pozos K, Barrera-Chimal J, Garzon-Muvdi J, Perez-Villalva R, Rodriguez-Romo R, Cruz C, Gamba G, Bobadilla NA. Recovery from ischemic acute kidney injury by spironolactone administration. Nephrol Dial Transplant. 2012 Aug;27(8):3160-9. doi: 10.1093/ndt/gfs014. Epub 2012 Apr 19.

    PMID: 22516623BACKGROUND

  • Barrera-Chimal J, Perez-Villalva R, Cortes-Gonzalez C, Ojeda-Cervantes M, Gamba G, Morales-Buenrostro LE, Bobadilla NA. Hsp72 is an early and sensitive biomarker to detect acute kidney injury. EMBO Mol Med. 2011 Jan;3(1):5-20. doi: 10.1002/emmm.201000105. Epub 2010 Dec 14.

    PMID: 21204265BACKGROUND

  • Prowle JR, Calzavacca P, Licari E, Ligabo EV, Echeverri JE, Haase M, Haase-Fielitz A, Bagshaw SM, Devarajan P, Bellomo R. Pilot double-blind, randomized controlled trial of short-term atorvastatin for prevention of acute kidney injury after cardiac surgery. Nephrology (Carlton). 2012 Mar;17(3):215-24. doi: 10.1111/j.1440-1797.2011.01546.x.

    PMID: 22117606BACKGROUND

  • Pretorius M, Murray KT, Yu C, Byrne JG, Billings FT 4th, Petracek MR, Greelish JP, Hoff SJ, Ball SK, Mishra V, Body SC, Brown NJ. Angiotensin-converting enzyme inhibition or mineralocorticoid receptor blockade do not affect prevalence of atrial fibrillation in patients undergoing cardiac surgery. Crit Care Med. 2012 Oct;40(10):2805-12. doi: 10.1097/CCM.0b013e31825b8be2.

    PMID: 22824930BACKGROUND

  • Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.

    PMID: 39878152DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Gerardo Gamba, PhD

    Instituto Nacional de la Nutrición Salvador Zubiran

    STUDY DIRECTOR

Central Study Contacts

Magdalena Madero, M.D.

CONTACT

55736902madero.magdalena@gmail.com

Michael E Wasung, M.D.

CONTACT

52591788mwasung@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

April 13, 2015

First Posted

April 16, 2015

Study Start

April 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

April 16, 2015

Record last verified: 2013-03

Locations

ME(2)