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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fluid restriction

    Dietary supplement

    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 protein supplementation

    Dietary supplement

    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.

  • Standard post-operative care

    Dietary supplement

    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.

Treatment groups

282 Participants
are divided into 3 treatment groups
Group A: Limited fluid intakeExperimental treatment 1 intervention
Group B: Additional proteinExperimental treatment 1 intervention
Group C: No instructionsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Odds ratio of treatment failure (intervention compared to standard of care)

The primary objective is to evaluate the effectiveness of fluid restriction (Treatment A), and dietary protein supplementation (Treatment B) compared to the current standard care with no specific intervention and no fluid management guidance (Treatment C) in preventing treatment failure, defined at day 9 as a decrease in plasma sodium by at least 4 mmol/lL from baseline, and hyponatremia (plasma sodium \<135mmol/L) or a decrease of at least 1 point in the MoCa score compared to baseline.

Time frame
3 days post-surgery (time of randomization), and day 9 post-surgery.

Secondary outcomes

Other outcomes

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