Spironolactone on Acute Kidney Injury in Critically Ill Patients

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.

Conditions

• Acute Kidney Injury

Interventions

DRUG

Spironolactone 25 mg

A dose of 25 mg of spironolactone will be administered orally or through the nasogastric /nasoenteral tube to the patients every 24 hours, at 8-9 am.

DRUG

Placebo oral capsule

The contents of a placebo capsule will be administered orally or through the nasogastric / nasoenteral tube to the patients every 24 hours, at 8-9 am.

Sponsors & Collaborators

• National Council of Science and Technology, Mexico

  collaborator OTHER

• Universidad Nacional Autonoma de Mexico

  collaborator OTHER

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  lead OTHER

Principal Investigators

• Norma Bobadilla-Sandoval, PhD · INCMNSZ / IBB UNAM

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-08-01

Primary Completion

2019-12-31

Completion

2019-12-31