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

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Cancerologia de Mexico
• Treatments: Spironolactone

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.