Clinical trial NCT02727686: Post-Operative Water Load Following Transsphenoidal Pituitary Surgery
Official title: Post-Operative Water Load Following Transsphenoidal Pituitary Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyponatremia
Pituitary Adenoma
Keywords: transsphenoidal pituitary surgery
Lead sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Sponsor class: OTHER
Collaborators: name: Barrow Brain and Spine
name: Barrow Neurological Institute
First posted: 2016-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Delayed post-operative hyponatremia occurs in 5-20% of patients following pituitary surgery and typically occurs on post-operative day 5-10.This decline in sodium can occur rapidly and have serious consequences such as altered mental status, seizures, coma, and even death. Despite significant research into patient demographics and risk factors, the investigators have not been able to predict which patients will suffer from delayed post-operative hyponatremia to date. At the Barrow Neurological Institute, physicians currently utilize an outpatient screening protocol to monitor patients' sodium levels after surgery, but this has yet to be effective for reducing readmissions following pituitary surgery. The etiology of delayed post-operative hyponatremia has been linked to water and sodium dysregulation in the post-operative period. It has been shown that post-operative day 1-2 sodium levels are statistically lower in patients who develop delayed hyponatremia, however, the numerical differences are not large enough to guide clinical management. The investigators propose that a water load on post-operative day 1 may expose underlying sodium/water dysregulation in the early post-operative period. This would improve physicians' understanding of the pathophysiology of post-operative hyponatremia, and it may help to serve as a screening tool for these patients in the future.

Detailed description: Current standards are for screening of all post-operative transsphenoidal pituitary patients for sodium abnormalities in the POD(post-operative day)7-14 window. At the Barrow Neurological Institute, physicians have instituted a universal screening protocol for all post-operative patients wherein all patients have a serum sodium level drawn on POD5-7 and attempts are made to manage mild to moderate hyponatremia on an outpatient basis.This screening protocol has effectively identified delayed post-operative hyponatremia, however, it has yet to reduce readmissions for hyponatremia in these patients. The researchers propose that implementing a water load test on POD1 may facilitate outpatient screening in three ways: 1) The water load may identify a subset of patients who have appropriate water and sodium regulation after surgery and do not require close monitoring of outpatient sodium levels. 2) The water load may identify a subset of patients who are at risk for delayed hyponatremia and would benefit from strict counseling and closer outpatient monitoring. 3) The water load may identify a subset of patients with a moderate to severe reduction in serum sodium in response to the water load, and these patients may benefit from further monitoring in the hospital prior to discharge. If any of these scenarios hold true, this may change the way physicians monitor and treat patients following transsphenoidal surgery in the future. Furthermore, this protocol could be readily expanded to other neurosurgery practices and could facilitate care for future patients undergoing transsphenoidal pituitary surgery.

Eligibility criteria: Inclusion Criteria:

* 18-80 years of age
* Functioning or non-functioning pituitary adenoma
* Sodium level 135-145 prior to surgery

Exclusion Criteria:

* Enrolled in a separate pituitary research study
* Unable to provide his/her own consent
* Unable to take PO water
* Renal insufficiency
* Require maintenance corticosteroids pre-operatively
* TSH secreting tumor
* Patients who the treating surgeon deems a poor candidate for the water challenge
* Prisoners
* Pregnant women

Primary outcomes:
measure: POD1 Response Serum Sodium
timeFrame: Post-Operative Day 1
measure: POD1 Response Serum Osmolality
timeFrame: Post-Operative Day 1
measure: POD1 Response Urine Output
timeFrame: Post-Operative Day 1
measure: POD1 Response Vasopressin
timeFrame: Post-Operative Day 1
Secondary outcomes:
measure: Post-Discharge Response
timeFrame: Post-Operative Day 2-7
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Brain and Spine
state: Arizona
Study officials:
affiliation: Barrow Brain and Spine, Phoenix AZ
name: Andrew S Little, MD
role: PRINCIPAL_INVESTIGATOR
References:
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