Effects of Potassium Sparing Diuretics on Potassium Urinary Output, Plasma Levels and Cardiac Arrhythmias in Neurocritical Care Patients Receiving Mannitol Therapy for Cerebral Edema: double blind, placebo control, prospective, randomized, controlled clinical trial -The SPIDER-MAN Trial -

INTERVENTION: Pharmaceutical Form: Solution for injection INN or Proposed INN: Potassium canrenoate Concentration unit: mg milligram(s) Concentration number: 200‐ CONDITION: Acute Cerebral Edema ; MedDRA version: 14.1 Level: LLT Classification code 10057359 Term: Cerebellar edema System Organ Class: 10029205 ‐ Nervous system disorders PRIMARY OUTCOME: Main Objective: The primary end point of this prospective, randomized, controlled ‐ The “Sparing PotassIum DiurEtics in patients Receiving MANnitol: SPIDER‐MAN trial”‐; is to evaluate, in patients receiving neurocritical care for cerebral edema, the effects of a potassium sparing diuretic (canrenone) as an adjunct to mannitol therapy on potassium urinary excreti Primary end point(s): potassium urinary excretion measured by collecting urine output for the 24 hours from day 1st to day 8th Secondary Objective: The secondary end points are to record its effects on potassium plasma level, episodes of cardiac arrhythmias, and on the length of stay in the intensive care. INCLUSION CRITERIA: ‐ patients aged between 18 and 75 years ‐ admitted to neurocritical care unit for acute cerebral edema confirmed to Neuroimaging (TC) ‐Glasgow Coma Scale = 6 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range