NCT07273630 Effect of Protein Supplementation and Fluid Restriction on Plasma Sodium Levels in Patients Undergoing Pituitary Surgery
| NCT ID | NCT07273630 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Hyponatremia |
| Study Type | INTERVENTIONAL |
| Enrollment | 282 participants |
| Start Date | 2026-01-20 |
| Primary Completion | 2028-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 282 participants in total. It began in 2026-01-20 with a primary completion date of 2028-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Mirjam Christ-Crain, Prof. Dr. med.
PRINCIPAL INVESTIGATOR
University Hospital Basel, Endocrinology
Frequently Asked Questions
Who can join the NCT07273630 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hyponatremia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07273630 currently recruiting?
Yes, NCT07273630 is actively recruiting participants. Contact the research team at Mirjam.Christ-Crain@usb.ch for enrollment information.
Where is the NCT07273630 trial being conducted?
This trial is being conducted at Basel, Switzerland.
Who is sponsoring the NCT07273630 clinical trial?
NCT07273630 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Mirjam Christ-Crain, Prof. Dr. med. at University Hospital Basel, Endocrinology. The trial plans to enroll 282 participants.