Effect of Protein Supplementation and Fluid Restriction on Plasma Sodium Levels in Patients Undergoing Pituitary Surgery - a Randomized Open-label Active-controlled Trial -

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
University Hospital Basel
RECRUITING
Basel
Contact Information
Primary
Mirjam Christ-Crain, Prof. Dr. med.
Mirjam.Christ-Crain@usb.ch
0041 61 328 70 80
Backup
Michelle Mueller
0041 61 328 55 23
Time Frame
Start Date: 2026-01-20
Estimated Completion Date: 2028-10-01
Participants
Target number of participants: 282
Treatments
Experimental: Limited fluid intake
Patients will limit their total daily fluid intake
Experimental: Additional protein
Patients will consume additional protein daily
Active_comparator: No instructions
Patients will not receive specific instructions.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Basel, Switzerland

This content was sourced from clinicaltrials.gov

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