Fluid restrictionDietary protein supplementationStandard post-operative care
Fluid restriction: 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.
Dietary protein supplementation: 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.
Standard post-operative care: 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.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* Lactose intolerance, milk protein allergy, soy allergy, nuts allergy or known hypersensitivity or allergy to one of the components of the protein supplementation
* Inborn metabolic disorders implying carbohydrate, lipid, or protein metabolism
* Severe hepatic impairment (ALAT/ASAT \>3x upper limit) or advanced symptomatic liver disease defined as past or current hepatic encephalopathy, liver cirrhosis Child C, or decompensated (bleeding, jaundice, hepatorenal syndrome)
* Reduction of eGFR \<45 mL/min/1.73m² (KDIGO G3b, G4 and G5) or end stage renal disease (dialysis)
* Recently initiated (within the last 5 days) SGLT2 inhibitors, vaptans, or oral urea therapy
* Pregnancy or breastfeeding
* Lack of capacity or other reason preventing from giving informed consent or following study procedures.
Post-Inclusion Exclusion criteria (day 3 post-surgery, i.e.,time of randomization): - AVP deficiency diagnosed on post-operative day 3
Primary outcome measure(s)
Odds ratio of treatment failure (intervention compared to standard of care) — 3 days post-surgery (time of randomization), and day 9 post-surgery. 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.
Trial sites (1)
Facility
City
Region
Status
University Hospital Basel
Basel
Switzerland
Recruiting
More University Hospital, Basel, Switzerland trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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