Hyponatremia Study (Delayed Hyponatremia After Pituitary Surgery)

NCT03636568 | Completed

• 1 other identifier: 16-05023
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyponatremia; Hyponatremic; Pituitary Tumor; Pituitary; Surgery

Keywords

hyponatremia; hyponatremic; pituitary tumor; transsphenoidal resection; pituitary surgery; pituitary

Outcome Measures

Primary Outcomes (1)

• Development of hyponatremia or low sodium

  Sodium level \<135 mEq/L

  3-14 days after surgery

Study Arms (2)

Fluid restricted

EXPERIMENTAL

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)

Other: Fluid Restricted Group

Non Fluid Restricted

NO INTERVENTION

No fluid restriction

Interventions

Fluid Restricted Group OTHER

Patients will be started on a weight-based intravenous fluid replacement with D5 ½ NS on POD 0 (75 cc/hr for patients \< 70kg, 100 cc/hr for patients 70-100kg, and 125 cc/hr for patients \>100kg). Patients will be allowed to drink water freely after surgery on POD #0. 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). Prior to initiation of a fluid restriction all of the following criteria have to be met: 1. Serum Na level must be \< 145 mEq/l 2. Patient should be taking fluids by mouth 3. Patient should not have evidence of DI (as determined by endocrine team following patient) If a patient in Fluid Restricted group develops DI, the fluid restriction will be stopped/not initiated.

Fluid restricted

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Klaassen 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 DERIVED

MeSH Terms

Conditions

Hyponatremia; Pituitary Neoplasms; Pituitary Diseases

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Endocrine System Diseases

Study Officials

• Julie Silverstein, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 17, 2018
• Study Start: June 2, 2016
• Primary Completion: July 22, 2024
• Study Completion: July 22, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

US (1)