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Clinical Trials/EUCTR2012-004071-39-IT
EUCTR2012-004071-39-IT
Active, Not Recruiting
N/A

Study on the effectiveness and safety of the treatment of mild-moderate symptomatic hyponatremia due to syndrome of inappropriate secretion of antidiuretic hormone (SIADH) with Tolvaptan vs fluid restriction in patients who underwent transsphenoidal surgery for hypothalamic-pituitary disorders.

FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO0 sitesOctober 31, 2012
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DrugsSAMSCA*10CPR 15MG

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
Status
Active, Not Recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 31, 2012
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO

Eligibility Criteria

Inclusion Criteria

  • •\- age \>18
  • •\- admission to Neurosurgery Unit for pituitary surgery
  • •\- Serum sodium levels lower than 135 mEq/l and higher than 120 mEq/l
  • •\- One or more symptoms of hyponatremia
  • •\- Euvolemic patient
  • •\- Informed consent
  • •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 10

Exclusion Criteria

  • •\- Impaired renal function(grade IV KDOQI)
  • •\- Liver failure
  • •\- Hypovolemia
  • •\- Hyponatremic hypovolemia
  • •\- Lack of sense to thirst
  • •\- Cotreatment with inhibitors/inductors of CYP3A4
  • •\- Pregnancy
  • •\- Brestfeeding

Outcomes

Primary Outcomes

Not specified

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