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New treatment option for Hyponatremia
Official title Effect of Protein Supplementation and Fluid Restriction on Plasma Sodium Levels in Patients Undergoing Pituitary Surgery
ClinicalTrials.gov ID: NCT07273630
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Inborn metabolic disorders implying carbohydrate, lipid, or protein metabolism
See the full eligibility 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Switzerland
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.