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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031240258
Enrollment
50
Registered
2024-08-06
Start date
2024-10-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonfunctioning pituitary neuroendcrine tumor pituitary neuroendocrine tumor

Interventions

Sodium chloride load

Sponsors

Kino Hiroyoshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Incidence and safety evaluation of hypernatremia, hypertension, and renal dysfunction associated with salt loading (1.8 g/day, 5 days)

Secondary

MeasureTime frame
Frequency, timing, and grade of hyponatremia on postoperative days 3 through 7, and evaluation of risk factors for the development of hyponatremia.

Contacts

Public ContactHiroyoshi Kino

University of Tsukuba Hospital

kino.H@md.tsukuba.ac.jp+81-298533220

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026