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Effect of Protein Supplementation and Fluid Restriction on Plasma Sodium Levels in Patients Undergoing Pituitary Surgery

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Basel, Switzerland
NCT07273630 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Fluid restriction
  • Dietary protein supplementation
  • Standard post-operative care
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Where

1 site
University Hospital Basel
Basel, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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