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Clinical Trials/EUCTR2011-000197-53-IT
EUCTR2011-000197-53-IT
Active, not recruiting
Not Applicable

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

AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA0 sitesMarch 5, 2012
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ConditionsAcute Cerebral EdemaMedDRA version: 14.1Level: LLTClassification code 10057359Term: Cerebellar edemaSystem Organ Class: 10029205 - Nervous system disorders

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Cerebral Edema
Sponsor
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 5, 2012
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

Eligibility 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

  • •unstable respiratory and hemodynamic conditions
  • •\- oliguric renal failure
  • •\- haemoglobin content of \<10\.0 mg/dl
  • •\- serum osmolality of \>320 mOsm/kg
  • •\- a concomitant use of thiopentone.

Outcomes

Primary Outcomes

Not specified

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