None listed
Conditions
Brief summary
This study is investigating the efficacy of prophylactic fluid restriction for prevention of low sodium levels after pituitary surgery. Who is it for? You may be eligible for this study if you are aged 18 years or older and are undergoing pituitary surgery for a pituitary tumour (functional and non-functional pituitary adenomas, Rathke’s cleft cyst, craniopharyngioma, other). Study details Participants will be randomly allocated to either a fluid restriction protocol (1L of fluid per day for days 4-9 post-pituitary surgery) or a protocol of no fluid restriction. Blood samples as well as data on hospital readmission rates and adverse events will be collected and analysed. It is hoped that information from this study will help inform future management of pituitary surgery patients and prevention of electrolyte disturbances.
Interventions
This study will investigate the effectiveness of a fluid restriction (1L/day between days 4-9 post-pituitary surgery) to reduce the incidence of delayed hyponatraemia from syndrome of inappropriate antidiuretic hormone (SIADH), which typically occurs between days 7-10 following pituitary surgery.
Participants in both groups will be asked to keep a fluid balance record during this time, which will be used to assess adherence. Participants are usually discharged from hospital by day 4 post-operat
This study will investigate the effectiveness of a fluid restriction (1L/day between days 4-9 post-pituitary surgery) to reduce the incidence of delayed hyponatraemia from syndrome of inappropriate antidiuretic hormone (SIADH), which typically occurs between days 7-10 following pituitary surgery. Participants in both groups will be asked to keep a fluid balance record during this time, which will be used to assess adherence. Participants are usually discharged from hospital by day 4 post-operatively, therefore most participants will be at home during the time of the intervention.
Sponsors
Princess Alexandra hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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: o Diuretic 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.
Outcome results
None listed