Effects of Empagliflozin compared with placebo in cardiorenal syndrome type 1, evaluated by MAKE30.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Empagliflozin 10 MG
Matching placebo containing Lactose content (0.26 gram)
Faculty of Medicine, Chulalongkorn University
Bangkok, Pathumwan, Thailand
RECRUITINGMAKE30
The composite outcome of death, new dialysis, and sustained loss of kidney function (which was defined as a 25% or greater decline in eGFR from baseline) assess at 30 days following randomization
Time frame: 30 days
In-hospital mortality rate
In-hospital mortality rate
Time frame: During admission
30-days mortality rate
30-days mortality rate
Time frame: 30 days
Initiation of Renal Replacement therapy
Initiation of Renal Replacement therapy
Time frame: 30 days
Sustained loss of kidney function defined as a 25% or greater decline in eGFR at 30 days following randomisation compared to baseline eGFR
Sustained loss of kidney function defined as a 25% or greater decline in eGFR at 30 days following randomisation compared to baseline eGFR
Time frame: 30 days
Recurrent heart failure
Recurrent heart failure required hospital administration
Time frame: 30 days
Vasoactive drug
Vasoactive drug use
Time frame: 30 days
Mechanical ventilation
Mechanical ventilation use
Time frame: 30 days
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Ventricular tachycardia or ventricular fibrillation
Ventricular tachycardia or ventricular fibrillation
Time frame: 30 days
Resuscitation following a cardiac arrest
Resuscitation following a cardiac arrest
Time frame: 30 days
Reduction of prespecified renal biomarkers
Reduction of prespecified renal biomarkers
Time frame: 30 days