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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 - - SpiderMan Trial

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 - - SpiderMan Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-000197-53-IT
Enrollment
Unknown
Registered
2012-03-05
Start date
2011-04-15
Completion date
Unknown
Last updated
2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Cerebral Edema MedDRA version: 14.1 Level: LLT Classification code 10057359 Term: Cerebellar edema System Organ Class: 10029205 - Nervous system disorders

Interventions

Pharmaceutical Form: Solution for injection INN or Proposed INN: Potassium canrenoate Concentration unit: mg milligram(s) Concentration number: 200-

Sponsors

AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: unstable respiratory and hemodynamic conditions - oliguric renal failure - haemoglobin content of 320 mOsm/kg - a concomitant use of thiopentone.

Design outcomes

Primary

MeasureTime frame
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;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.;Primary end point(s): potassium urinary excretion measured by collecting urine output for the 24 hours from day 1st to day 8th—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026