Spironolactone on Acute Kidney Injury in Critically Ill Patients
Status:
Unknown status
Trial end date:
2019-12-31
Target enrollment:
Participant gender:
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
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