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

NCT07273630 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2026-02-03

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Fluid restriction

Patients will limit their total daily fluid intake to a maximum of 1000 ml, including any liquids of their choice, such as water, milk, or juice.

DIETARY_SUPPLEMENT

Dietary protein supplementation

Patients will consume an additional 80 grams of protein daily through two 150 ml protein drinks (40 grams of protein each, MOLTEIN PURE Drink, OMANDA) in various flavors. They can distribute the drinks throughout the day and drink other fluids freely based on thirst.

DIETARY_SUPPLEMENT

Standard post-operative care

Patients will not receive specific instructions on protein supplementation or fluid restriction. They will follow standard post-operative care and drink or eat freely based on natural appetite and thirst.

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Mirjam Christ-Crain, Prof. Dr. med. · University Hospital Basel, Endocrinology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2028-10-01
Completion
2028-10-01

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07273630 on ClinicalTrials.gov