Clinical trial · Interventional
Hyponatremia Study (Delayed Hyponatremia After Pituitary Surgery)
Early Fluid Restriction to Prevent Delayed Hyponatremia Following Pituitary Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyponatremia | — | UNRESOLVED | — |
| Hyponatremic | — | UNRESOLVED | — |
| Pituitary | — | UNRESOLVED | — |
| Pituitary Tumor | Pituitary Gland Neoplasm | ALIAS | 0.90 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluid Restricted Group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fluid restricted
- description
- Fluids will be stopped at 8am on POD 1 and patients will be started on a moderate fluid restriction on POD #3 based on their weight (1000 cc/24 hours for patients who weigh \<=100 kg and 1200 cc/24 hours for patients who weigh \> 100kg)
- interventionNames
- Other: Fluid Restricted Group
- type
- NO_INTERVENTION
- label
- Non Fluid Restricted
- description
- No fluid restriction
Primary outcomes (1)
- measure
- Development of hyponatremia or low sodium
- timeFrame
- 3-14 days after surgery
- description
- Sodium level \<135 mEq/L
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKlaassen D, Mok S, Hwang JY, Blount SL, Williams KJ, Fong BM, Chicoine MR, Dacey RG, Farrell NF, Osbun JW, Rich KM, Roland LT, Schneider JS, Zipfel GJ, Luo C, Kim AH, Silverstein JM. Postoperative fluid restriction to prevent delayed hyponatremia after endoscopic transsphenoidal surgery. Neuro Oncol. 2025 Sep 8;27(7):1746-1757. doi: 10.1093/neuonc/noaf069. PMID 40084913