About this trial
The investigators are conducting this study to investigate new preventive measures for patients with low sodium levels (hyponatremia), which can occur after surgery on the pituitary gland. This hyponatremia is often caused by the syndrome of inappropriate antidiuresis (SIAD). SIAD occurs when the pituitary gland secretes too much antidiuretic hormone. The antidiuretic hormone causes the kidneys to absorb more water. This dilutes the sodium in the blood and leads to hyponatremia. Low sodium levels are particularly common after pituitary surgery, as the procedure on the pituitary gland can lead to increased reactive secretion of antidiuretic hormone. At present, apart from educating patients about the symptoms of hyponatremia, there are no established standard measures for prevention after pituitary surgery. If hyponatremia is present, it is currently treated primarily by fluid restriction, which is not always pleasant or easy to adhere to. With this study, the investigators want to investigate whether protein supplementation or fluid restriction between day 4 and day 9 after surgery can serve as a preventive measure to stabilize sodium levels after pituitary surgery and improve the quality of life of patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (aged 18 or older) undergoing trans-sphenoidal or trans-cranial surgery for sellar / suprasellar pathology
No pre-existing AVP-deficiency and SIAD or other causes of hyponatremia
Disqualifiers
AVP deficiency diagnosed before surgery based on established criteria
Other type of neurosurgery / intracranial pathology / pre-existing spontaneous CSF -rhinorrhea
Traumatic brain injury or intracranial hemorrhage
Systemic infection or other causes for systemic stress
Trial design
Parallel
Treatments tested in this trial
Fluid restriction
Dietary supplementPatients will limit their total daily fluid intake to a maximum of 1000 ml, including any liquids of their choice, such as water, milk, or juice.
Dietary protein supplementation
Dietary supplementPatients will consume an additional 80 grams of protein daily through two 150 ml protein drinks (40 grams of protein each, MOLTEIN PURE Drink, OMANDA) in various flavors. They can distribute the drinks throughout the day and drink other fluids freely based on thirst.
Standard post-operative care
Dietary supplementPatients will not receive specific instructions on protein supplementation or fluid restriction. They will follow standard post-operative care and drink or eat freely based on natural appetite and thirst.
Treatment groups
Trial outcomes
Primary outcomes
Odds ratio of treatment failure (intervention compared to standard of care)
The primary objective is to evaluate the effectiveness of fluid restriction (Treatment A), and dietary protein supplementation (Treatment B) compared to the current standard care with no specific intervention and no fluid management guidance (Treatment C) in preventing treatment failure, defined at day 9 as a decrease in plasma sodium by at least 4 mmol/lL from baseline, and hyponatremia (plasma sodium \<135mmol/L) or a decrease of at least 1 point in the MoCa score compared to baseline.
Sponsors and contacts
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