Spironolactone on Acute Kidney Injury in Critically Ill Patients

• Status: Unknown status
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study was designed to evaluate the effect of spironolactone administration in the incidence and severity of AKI in patients critically ill with invasive mechanical ventilation (IMV) in the critical care unit.

Patients in critical care unit (CCU) are the most at risk of developing AKI. In most cases a mechanism of ischemia/reperfusion has a central role in the development of AKI. Aldosterone has traditionally been recognized as a mediator that maintains water and sodium homeostasis. Nevertheless, there are enough evidence in humans and experimental models that aldosterone might mediate detrimental effects on renal function and structure in pathophysiological conditions. Indeed, several experimental studies from our laboratory have shown that mineralocorticoid receptor blockade protects the kidney against ischemia/reperfusion injury.

The aim of this study is to know:

o If mineralocorticoid receptor blockade may reduce the incidence and severity of AKI in critically patients with IMV in CCU.

You may be able to enter in this study if:

• You are at least 18 years old.

• You are male or female

• You are with IMV.

• You are in CCU.

• Your serum K is less than 4.5 mEq/L

• Your BP is >90/70 mmHg

You cannot enter this study if:

• You have CKD

• You have AKI

This study will recruit 90 patients from Instituto Nacional de Ciencias Médicas Salvador Zubiran in México City. The study will begin in April 2017. The patients will be randomized to one of 2 groups of treatment (Spironolactone 25 mg or placebo). All treatments looks identical (1 capsule), will be administered through the nasogastric tube. Neither the patients nor their doctors will be able to know or decide which group you are in. You will receive the medication during the first five days of stay in the critical care unit.

As part of this trial, the doctors will ask your permission to get a sample urine during this days. They will use the samples to do tests in the laboratory (different to routine tests) that may help them to compare renal function and biomarkers of renal injury. Your participation will end 10 days after your entry into the critical care unit. The most common side effect of spironolactone is hyperkalemia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Collaborators: National Council of Science and Technology, Mexico; Universidad Nacional Autonoma de Mexico
• Treatments: Spironolactone

Criteria

Inclusion Criteria:

• Patients older than 18 years of age

• Patients critically ill requiring invasive mechanical ventilation with some organic failure in addition to respiratory failure.

Organic scale failure will be categorized according to the (Sequential Organ Failure Assesment) scale and will be considered present when there is a score ≥2 in some organ / system, except renal.

• Patients with normal renal function or chronic kidney disease KDOQI 1-3

• Patients without acute renal injury according to the (acute kidney injury network) AKIN criteria.

• Normal serum K levels (less than or equal to 5 mEq / L).

• Women with (a) negative pregnancy test, (b) surgical sterilization, or (c) completed menopause.

• Systolic blood pressure> 90 mmHg and mean arterial pressure> 70 mmHg.

• Diuresis in the first 6 hrs from admission to intensive therapy> 0.5 ml / kg / hr.

• The patient will give written and signed informed consent prior to any specific study procedure. However, if a patient can not do so before, his or her legal representative the Institute may give written informed consent.

Exclusion Criteria:

• Patients with chronic kidney disease stages 4-5 of KDOQI / renal replacement therapy.

• Patients with acute kidney injury according to the AKIN criteria at the time of admission to the intensive care unit

• Patients with refractory septic shock, defined as a state of hypotension requiring administration of ≥0.25 mcg / kg / min of noradrenaline.

• Patients with known adrenal insufficiency.

• Patients with indication for the administration of angiotensin-converting enzyme (ACE) blockers or angiotensin 2 receptor antagonists.

• Known allergy to spironolactone.

• Contraindication for orally medication or placement of any probe (SNG or SNE)

• It is considered that the patient is unlikely to survive the study period (30 days) or has a disease of rapid or terminal progression.

• The patient is participating in any other clinical trial involving the administration of a research drug at the time of the presentation during the course of the study or has been treated with a research drug within 30 days prior to enrollment.

• The patient has been enrolled in this study previously.

• The patient is pregnant or breastfeeding.