Surgery Clinical Trial
— DHAPSOfficial title:
Early Fluid Restriction to Prevent Delayed Hyponatremia Following Pituitary Surgery
Verified date | April 2023 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 300 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Barnes Jewish Hospital | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Development of hyponatremia or low sodium | Sodium level <135 mEq/L | 3-14 days after surgery |
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