Delayed hyponatremia after pituitary tumor surgery
Conditions
Interventions
tolvaptan group:Orally administered tolvaptan
placebo group:oral placebo
Sponsors
Second Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–70 years; 2. Sexr No restriction; 3. Tumor diameter >=1 cm; 4. First-time endoscopic transsphenoidal surgery (eTSS); 5. Pathologically confirmed pituitary adenoma (all subtypes); 6. Normal serum sodium level on postoperative day 4; 7. Written informed consent obtained.
Exclusion criteria
Exclusion criteria: 1. ACTH-secreting adenoma; 2. Adrenal insufficiency (morning 8:00 cortisol level 3×ULN, or total bilirubin >2×ULN); 6. Renal insufficiency (eGFR <30 mL/min); 7. Current diuretic use; 8. Pregnancy/lactation; 9. Tolvaptan hypersensitivity; 10. Autosomal dominant polycystic kidney disease (ADPKD); 11. Diabetes mellitus; 12.Patients requiring emergent surgical intervention; 13. Non-compliant patients or those unable to cooperate with study procedures; 14. Intracranial infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hyponatremia on postoperative day 7; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of pituitary-adrenal insufficiency and pituitary-hypothyroidism on the 7th postoperative day;Incidence of adverse drug reactions (ADRs); | — |
Countries
China
Contacts
Public ContactSong Li
Second Affiliated Hospital of Army Medical University
Outcome results
None listed