Ignite Creation Date:
2024-05-06 @ 8:24 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02727686
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2016-03-23
Brief Title:
Post-Operative Water Load Following Transsphenoidal Pituitary Surgery
Sponsor:
St Josephs Hospital and Medical Center Phoenix
Organization:
St Josephs Hospital and Medical Center Phoenix
Study Overview
Official Title:
Post-Operative Water Load Following Transsphenoidal Pituitary Surgery
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Delayed post-operative hyponatremia occurs in 5-20 of patients following pituitary surgery and typically occurs on post-operative day 5-10This 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 sodiumwater 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 PODpost-operative day7-14 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 basisThis 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None