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Spironolactone Administration to Prevent Ischemic Kidney Injury in Critically Ill Cancer Patients (SPIROCAN)

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ClinicalTrials.gov Identifier: NCT02531412
Recruitment Status : Recruiting
First Posted : August 24, 2015
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Bertha Cordova-Sanchez, Instituto Nacional de Cancerologia de Mexico

Brief Summary:

Acute kidney injury frequently affects cancer patients. The main cause of acute kidney injury is ischemic damage caused by transient decrease in renal blood flow, followed by blood flow restoration and accompanying reperfusion injury (ischemia-reperfusion injury. Several studies, mainly in animal models have tried to establish spironolactone role on kidney injury induced by ischemia-reperfusion injury. It has been demonstrated in renal transplant recipients that the administration of spironolactone can prevent oxidative stress and is safe. The group of cancer patients with states capable of producing tissue hypoperfusion (hypovolemic shock, heart failure, major surgery, use of anesthetics) are at increased risk of developing acute renal ischemia-reperfusion injury.

The investigators hypothesis is that spironolactone may be useful in preventing acute renal injury when administered during the first six hour of renal ischemia-reperfusion insult.

The purpose of this study is to determine the utility of spironolactone administered after an ischemic renal insult (major surgery) to prevent acute kidney injury in critically cancer patients.

Investigators propose a pilot study, randomized, double blind, placebo controlled trial, approved by the local ethical committee, to compare the efficacy of spironolactone to prevent acute kidney injury in patients after major surgery. Investigators will include 12 patients in spironolactone group (25mg daily for three days) and 12 patients in placebo group.


Condition or disease Intervention/treatment Phase
Critically Ill Cancer Drug: Spironolactone Drug: Placebo Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Spironolactone Administration to Prevent Ischemic Kidney Injury in Critically Ill Cancer Patients
Study Start Date : October 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Spironolactone
Spironolactone 25 mg PO daily for three days. During five days investigators will collect values of plasma creatinine, sodium, potassium, blood ureic nitrogen, vital signs and urinary output.
Drug: Spironolactone
After a major surgery event a time 0, 24h and 48h
Other Name: Aldactone

Placebo Comparator: Placebo
Placebo 25mg PO daily for three days During five days investigators will collect values of plasma creatinine, sodium, potassium, blood ureic nitrogen, vital signs and urinary output.
Drug: Placebo
After a major surgery event a time 0, 24h and 48h




Primary Outcome Measures :
  1. Acute kidney injury by 0.3 creatinine elevation [ Time Frame: 48 hours ]
    Elevation of creatinine to 0.3mg/dL above baseline in the last 48 hours

  2. Acute kidney injury by 1.5 times creatinine elevation [ Time Frame: 48 hours ]
    Elevation of baseline creatinine 1.5 times above baseline

  3. Acute kidney injury by urinary output [ Time Frame: 48 hours ]
    Decreased urine output less than 0.5ml/kg/hr over a period of 6 continuous hours somewhere during the first 48 hours monitoring, after admission to the intensive care unit


Secondary Outcome Measures :
  1. Hyperkalemia [ Time Frame: Up to 5 days ]
    Serum potassium above 5.1mE/L



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients admitted to the ICU in the immediate postoperative period (first 24 hours) of major surgery, defined as involving general anesthesia, ventilation, opening of large cavities (cranial, thoracic, abdominal).
  • Patients with informed consent signed by them or their responsible relative.
  • Patients who are likely to survive at least 48 hours after admission to the ICU.
  • Patients who have measured "baseline" creatinine before UCI admission, in the last three months.

Exclusion Criteria:

  • Patients who have contraindications for enteral medications.
  • Patients who have acute kidney injury at the time of admission.
  • Patients on renal replacement therapy prior to ICU admission.
  • Patients with previous diagnosis of chronic kidney disease G3b stage.
  • Patients with plasma potassium greater than 5.1mEq/L.
  • Hypersensitivity to spironolactone.
  • Septic shock.
  • Obstructive uropathy.
  • Renal transplantation.
  • Postoperative period of nephrectomy.
  • Pregnancy.
  • Known adrenal insufficiency.
  • Patients requiring a higher dose of norepinephrine 0.1mcg/kg/min for more than an hour to maintain mean arterial pressure equal to or greater than 70mmHg even after receiving fluid resuscitation.
  • Patients requiring the administration of inhibitors of angiotensin-converting enzyme (ACE) for its management.
  • Patients requiring an increase of 25% or more of the dose of norepinephrine to maintain mean arterial pressure equal of greater than 70mmHg during follow up.

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): NCT02531412


Contacts
Contact: Bertha M Cordova-Sanchez, MD 5556280400 ext 13082 berthax@hotmail.com
Contact: Silvio A Ñamendys-Silva, MD 5556280400 ext 13082 snamendys@incan.edu.mx

Locations
Mexico
Nacional Cancer Institute Recruiting
Mexico, Distrito Federal, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
Investigators
Principal Investigator: Bertha M Cordova-Sanchez, MD Instituto Nacional de Cancerologia, Columbia

Responsible Party: Dr. Bertha Cordova-Sanchez, MD, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT02531412     History of Changes
Other Study ID Numbers: CEI/993
First Posted: August 24, 2015    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. Bertha Cordova-Sanchez, Instituto Nacional de Cancerologia de Mexico:
Acute kidney injury
Critically ill cancer patients
Spironolactone

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents