Effect of fluid restriction on incidence of delayed hyponatraemia post pituitary surgery

Not Applicable

Recruiting

• Conditions: Diabetes insipidus; Metabolic and Endocrine - Other endocrine disorders; Surgery - Other surgery

• Registration Number: ACTRN12621001016820
• Lead Sponsor: Princess Alexandra hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-04
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Percent of patients developing delayed hyponatraemia/SIADH within 30 days of surgery. Defined by: SIADH occurring days 4-11 post pituitary surgery with serum sodium < 134 mEq/l and low serum osmolality (<275 mOsm/l), euvolemic status, and normal renal, thyroid and adrenal function (and/or pituitary hormone replacement).<br>Participants blood tests results will be reviewed to assess the occurrence of hyponatremia post-pituitary surgery. <br>[Delayed hyponatraemia from SIADH following pituitary surgery occurs within the first month of surgery. The time point therefore will be 1 month post-pituitary surgery for each participant. ]