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.
Disturbances in water balance, often due to disturbed arginine vasopressin (AVP) secretion from pituitary stalk and/or posterior lobe damage/manipulation, are common complications following pituitary surgery. This can result in either AVP deficiency, causing polyuria and polydipsia, or AVP excess, leading to water retention and dilutional hyponatremia (syndrome of inappropriate antidiuresis, SIAD). SIAD affects up to 30% of patients, typically developing between days 4 and 14 post-surgery, with a peak around day 7. While usually mild, severe hyponatremia is a leading cause of hospital readmission. Management includes fluid restriction, oral urea, or, in severe cases, hypertonic saline and AVP receptor antagonists. Non-medicinal preventive strategies, such as prophylactic fluid restriction, have demonstrated efficacy in reducing SIAD incidence and hospital readmissions, but the optimal protocol remains unestablished. Dietary protein supplementation has recently emerged as a potential novel intervention, leveraging osmotic diuresis from increased endogenous urea production derived from the physiological amino-acid metabolism to raise plasma sodium levels. However, no data in the postoperative setting are available This study aims to compare protein supplementation and fluid restriction to standard care (no specific intervention) in preventing post-pituitary surgery hyponatremia. From days 4 to 9 post-surgery, participants will receive one of the three treatments: Treatment A: Patients will limit their total daily fluid intake to a maximum of 1000 ml Treatment B: Patients 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. Treatment C: Patients will not receive specific instructions. They will follow standard post-operative care and serve as a control group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
282
Patients 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.
Patients 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.
Patients 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.
University Hospital Basel
Basel, Switzerland
RECRUITINGOdds 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.
Time frame: 3 days post-surgery (time of randomization), and day 9 post-surgery.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.