Preventing low blood sodium after pituitary surgery with extra protein or fluid restriction
Official title: Effect of Protein Supplementation and Fluid Restriction on Plasma Sodium Levels in Patients Undergoing Pituitary Surgery - a Randomized Open-label Active-controlled Trial -
Run by University Hospital, Basel, Switzerland · NCT07273630 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 282 (estimated) |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Status | Recruiting |
| Started | January 20, 2026 |
| Main results expected | October 1, 2028 |
| Study ends | October 1, 2028 |
| Registry record updated | February 3, 2026 |
| Trial ID | NCT07273630 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Intranasal oxytocin to help with pain after pituitary surgery
This study tests whether intranasal oxytocin can reduce pain after pituitary surgery and improve recovery.
-
Protein supplementation for treating low sodium levels in hospitalized patients
This study is testing if giving extra protein to hospitalized patients with low sodium levels works better and is more acceptable than limiting their fluid intake.
-
Managing sodium levels in patients with severe kidney disease
This study tests how giving water and salt to adults with severe kidney disease can help balance their sodium levels and improve their health.
-
Using DDAVP to prevent sodium overcorrection in severe hyponatremia
This study is testing if adding a medication called DDAVP to standard treatment can help ICU patients with severe low sodium levels avoid dangerous complications from rapid sodium changes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.