Preventing low blood sodium after pituitary surgery with extra protein or fluid restriction
Effect of Protein Supplementation and Fluid Restriction on Plasma Sodium Levels in Patients Undergoing Pituitary Surgery - a Randomized Open-label Active-controlled Trial -
This study tests whether taking extra dietary protein or temporarily limiting fluids after pituitary surgery helps prevent low blood sodium (hyponatremia) in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 282 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT07273630 on ClinicalTrials.gov |
What this trial studies
Patients who have had transsphenoidal or transcranial pituitary surgery will be assigned to one of three approaches between days 4 and 9 after operation: dietary protein supplementation, fluid restriction, or standard postoperative care. Plasma sodium levels and clinical outcomes will be monitored during the intervention period and at follow-up to compare how often hyponatremia develops and whether hospital readmissions are affected. The trial focuses on non-drug, easily delivered interventions to reduce the common postoperative syndrome of inappropriate antidiuresis (SIAD). Safety monitoring will screen for intolerance or contraindications to the protein supplement and for complications of fluid restriction.
Who should consider this trial
Good fit: Adult patients (18 years or older) undergoing transsphenoidal or transcranial pituitary surgery who do not have pre-existing AVP deficiency or other causes of hyponatremia.
Not a fit: Patients with pre-existing AVP deficiency, significant liver disease, metabolic disorders, or allergies to the protein supplement components are excluded and unlikely to benefit from these interventions.
Why it matters
Potential benefit: If successful, the interventions could reduce postoperative hyponatremia and lower the rate of readmission after pituitary surgery.
How similar studies have performed: Prophylactic fluid restriction has shown benefit in prior work, while dietary protein supplementation is a newer, physiologically plausible idea with promising rationale but no postoperative data yet.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Basel
- University Hospital Basel — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Mirjam Christ-Crain, Prof. Dr. med. — University Hospital Basel, Endocrinology
- Study coordinator: Mirjam Christ-Crain, Prof. Dr. med.
- Email: Mirjam.Christ-Crain@usb.ch
- Phone: 0041 61 328 70 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.