CompletedNot Applicable

Hyponatremia Study (Delayed Hyponatremia After Pituitary Surgery)

United States300 participantsStarted 2016-06-02

Plain-language summary

Hyponatremia is defined as sodium below the normal range of 135-145. Symptomatically, it can cause patients to experience a wide range of symptoms including lethargy, headache, nausea, vomiting and in severe cases coma and even death. The goal of this study is to prospectively compare two approaches to the postoperative fluid management of patients undergoing transsphenoidal resection of a pituitary tumor or cyst to decrease the occurrence of postoperative delayed hyponatremia. One group will be placed on moderate fluid restriction and the other group will be placed on ad lib fluid intake.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: • Any adult patient with a pituitary adenoma or cyst (either non-functioning, prolactin-secreting, growth hormone secreting, ACTH (adrenocorticotropic hormone)-secreting, gonadotropin secreting, or TSH secreting) scheduled to undergo pituitary resection. Exclusion Criteria: * Patients with a history of chronic hyponatremia * Patients with a history of SIADH (syndrome of inappropriate antidiuretic hormone) , except if secondary to hypothyroidism or adrenal insufficiency, or in association with prior TSS * Patients with diabetes insipidus or patients receiving DDAVP * Patients without an intact thirst mechanism * Patients with CKD (chronic kidney disease) stage III, IV or V * Patients with untreated adrenal insufficiency or hypothyroidism * Patients with class III or IV heart failure

What they're measuring

Development of hyponatremia or low sodium

Timeframe: 3-14 days after surgery

Trial details

NCT IDNCT03636568

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-22