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Clinical Trials/ACTRN12621001016820
ACTRN12621001016820
Recruiting
未知

A randomised trial of the effect of prophylactic fluid restriction on the incidence of delayed hyponatraemia following pituitary surgery in adults

Princess Alexandra hospital0 sites80 target enrollmentAugust 4, 2021

Overview

Phase
未知
Intervention
Not specified
Conditions
Diabetes insipidus
Sponsor
Princess Alexandra hospital
Enrollment
80
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 4, 2021
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\.Undergoing pituitary surgery
  • 2\.Pituitary tumour (functional and non\-functional pituitary adenomas, Rathke’s cleft cyst, craniopharyngioma, other)
  • 3\.Adults 18 years of age or older
  • 4\.Willingness and able to give written or oral informed consent and willingness to participate to and comply with the study.

Exclusion Criteria

  • Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study, as pregnancy may interfere with the results of the study, and this group would make up an extremely small number of patients undergoing pituitary surgery.
  • Participants with a history of a psychological illness or condition such as to interfere with the participant’s ability to understand the requirements of the study.
  • Participants with diabetes mellitus and significant hyperglycaemia postoperatively (blood glucose levels greater than 12 mmol/L) or who have other causes of osmotic diuresis.
  • The following medication(s) can have interactive effects and may interfere with the participants ability to meet the study requirements; they cannot be administered during the clinical study:
  • oDiuretic medications, mannitol, medications known to affect plasma sodium (including SSRIs, TCAs, anti\-epileptics medications)
  • Any patient with a pre\-existing diagnosis of DI, or those requiring DDAVP on discharge (usually around day 4 post\-op), or other medical condition where fluid restriction would be considered dangerous.

Outcomes

Primary Outcomes

Not specified

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