A multicenter trial to evaluate the safety and efficacy of preventative sodium chloride dosing for postoperative hyponatremia in pituitary neuroendocrine tumors

JRCT ID: jRCTs031240258

Registered date:06/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Nonfunctioning pituitary neuroendcrine tumor
• Date of first enrollment: 30/10/2024
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Sodium chloride load

Outcome(s)

• Primary Outcome: Incidence and safety evaluation of hypernatremia, hypertension, and renal dysfunction associated with salt loading (1.8 g/day, 5 days)
• Secondary Outcome: Frequency, timing, and grade of hyponatremia on postoperative days 3 through 7, and evaluation of risk factors for the development of hyponatremia.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1) Patients who have undergone endoscopic endonasal surgery for non-functioning pituitary neuroendocrine tumors
2) Patients with normal serum sodium levels
3) Patients who are between 18 and 75 years of age at the time of consent
4) Patients who have been fully informed of the study and have given their voluntary written consent based on their full understanding.

Exclude criteria

1) Patients on preoperative medication for endocrine dysfunction
2) Patients with pre- or post-operative diabetes insipidus (including transient) requiring medication
3) Patients with uncontrolled hypertension
4) Patients with a history of myocardial infarction, heart failure, or unstable angina
5) Patients with severe renal dysfunction (BUN over 25 mg/dL or serum creatinine over 2.0 mg/dL)
6) Pregnant and potential pregnant women
7) women who are breastfeeding
8) Patients who received other study or investigational products within 3 months prior to the start of study drug administration
9) Patients with prolonged postoperative impaired consciousness and difficulty in pain assessment
10) Patients deemed inappropriate as subjects by the investigators

Related Information

• Primary Sponsor: Kino Hiroyoshi
• Source(s) of Monetary Support: University of Tsukuba Hospital