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

Princess Alexandra hospital0 个研究点目标入组 80 人开始时间: 2021年8月4日最近更新: 2022年8月9日

适应症

试验速览

暂无简介。

•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.

•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.

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