Post-Operative Water Load Following Transsphenoidal Pituitary Surgery
Primary Purpose
Hyponatremia, Pituitary Adenoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water Load (WL) Post-Operative Day 1
Sponsored by
About this trial
This is an interventional supportive care trial for Hyponatremia focused on measuring 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
Sites / Locations
- Barrow Brain and Spine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Water Load (WL) Post-Operative Day 1
Arm Description
All enrolled subjects passing conditions outlined in Intervention are eligible to be included. WL will be calculated (20 mL/kg body weight) and supplied at the bedside. Patient will have 30 minutes to consume WL, or will be excluded.
Outcomes
Primary Outcome Measures
POD1 Response Serum Sodium
Evaluate patients' responses to water load on the morning of post-operative day 1: serum sodium (normal range 135-145 mmol/L)
POD1 Response Serum Osmolality
Evaluate patients' responses to water load on the morning of post-operative day 1: serum osmolality (normal range 275-300 mOsm/kg)
POD1 Response Urine Output
Evaluate patients' responses to water load on the morning of post-operative day 1: urine output (normal range > 0.5 ml/kg/hr)
POD1 Response Vasopressin
Evaluate patients' responses to water load on the morning of post-operative day 1: vasopressin level (normal range 0.0 - 6.9 pg/ml)
Secondary Outcome Measures
Post-Discharge Response
Follow patients' serum sodium levels after discharge from the hospital and assess for any correlation in water load response and outpatient sodium levels. This is not done with a mathematical calculation but by observation of lab results. Hypothetically, normal water load response (serum sodium =135-145) will equate to normal outpatient sodium levels (135-145). Likewise, an abnormal water load response (sodium < 135 or >145) will equate to possible abnormal outpatient sodium levels (< 135, >145).
Full Information
NCT ID
NCT02727686
First Posted
March 23, 2016
Last Updated
November 21, 2019
Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Collaborators
Barrow Brain and Spine, Barrow Neurological Institute
1. Study Identification
Unique Protocol Identification Number
NCT02727686
Brief Title
Post-Operative Water Load Following Transsphenoidal Pituitary Surgery
Official Title
Post-Operative Water Load Following Transsphenoidal Pituitary Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 7, 2016 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
December 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Collaborators
Barrow Brain and Spine, Barrow Neurological Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyponatremia, Pituitary Adenoma
Keywords
transsphenoidal pituitary surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Water Load (WL) Post-Operative Day 1
Arm Type
Experimental
Arm Description
All enrolled subjects passing conditions outlined in Intervention are eligible to be included. WL will be calculated (20 mL/kg body weight) and supplied at the bedside. Patient will have 30 minutes to consume WL, or will be excluded.
Intervention Type
Other
Intervention Name(s)
Water Load (WL) Post-Operative Day 1
Intervention Description
Patient will have normonatremic 0600 hr sodium level (Serum Sodium = 135 - 145 mmol/L), ability to safely take water by mouth, and cleared to continue by treating surgeon. WL will be calculated (20 mL/kg body weight) and supplied at the bedside. Vasopressin level will be determined. Patient will have 30 minutes to consume WL, or will be excluded. Included patients will have data collected as follows: 1 hour - serum sodium, urine output; 2 hour - serum sodium, urine output, vasopressin level; 6 hours - serum sodium, urine output.
Primary Outcome Measure Information:
Title
POD1 Response Serum Sodium
Description
Evaluate patients' responses to water load on the morning of post-operative day 1: serum sodium (normal range 135-145 mmol/L)
Time Frame
Post-Operative Day 1
Title
POD1 Response Serum Osmolality
Description
Evaluate patients' responses to water load on the morning of post-operative day 1: serum osmolality (normal range 275-300 mOsm/kg)
Time Frame
Post-Operative Day 1
Title
POD1 Response Urine Output
Description
Evaluate patients' responses to water load on the morning of post-operative day 1: urine output (normal range > 0.5 ml/kg/hr)
Time Frame
Post-Operative Day 1
Title
POD1 Response Vasopressin
Description
Evaluate patients' responses to water load on the morning of post-operative day 1: vasopressin level (normal range 0.0 - 6.9 pg/ml)
Time Frame
Post-Operative Day 1
Secondary Outcome Measure Information:
Title
Post-Discharge Response
Description
Follow patients' serum sodium levels after discharge from the hospital and assess for any correlation in water load response and outpatient sodium levels. This is not done with a mathematical calculation but by observation of lab results. Hypothetically, normal water load response (serum sodium =135-145) will equate to normal outpatient sodium levels (135-145). Likewise, an abnormal water load response (sodium < 135 or >145) will equate to possible abnormal outpatient sodium levels (< 135, >145).
Time Frame
Post-Operative Day 2-7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew S Little, MD
Organizational Affiliation
Barrow Brain and Spine, Phoenix AZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrow Brain and Spine
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24053496
Citation
Hussain NS, Piper M, Ludlam WG, Ludlam WH, Fuller CJ, Mayberg MR. Delayed postoperative hyponatremia after transsphenoidal surgery: prevalence and associated factors. J Neurosurg. 2013 Dec;119(6):1453-60. doi: 10.3171/2013.8.JNS13411. Epub 2013 Sep 20.
Results Reference
background
PubMed Identifier
26348011
Citation
Bohl MA, Ahmad S, Jahnke H, Shepherd D, Knecht L, White WL, Little AS. Delayed Hyponatremia Is the Most Common Cause of 30-Day Unplanned Readmission After Transsphenoidal Surgery for Pituitary Tumors. Neurosurgery. 2016 Jan;78(1):84-90. doi: 10.1227/NEU.0000000000001003.
Results Reference
background
PubMed Identifier
9322839
Citation
Olson BR, Gumowski J, Rubino D, Oldfield EH. Pathophysiology of hyponatremia after transsphenoidal pituitary surgery. J Neurosurg. 1997 Oct;87(4):499-507. doi: 10.3171/jns.1997.87.4.0499.
Results Reference
background
PubMed Identifier
19199508
Citation
Kristof RA, Rother M, Neuloh G, Klingmuller D. Incidence, clinical manifestations, and course of water and electrolyte metabolism disturbances following transsphenoidal pituitary adenoma surgery: a prospective observational study. J Neurosurg. 2009 Sep;111(3):555-62. doi: 10.3171/2008.9.JNS08191.
Results Reference
background
PubMed Identifier
8559292
Citation
Taylor SL, Tyrrell JB, Wilson CB. Delayed onset of hyponatremia after transsphenoidal surgery for pituitary adenomas. Neurosurgery. 1995 Oct;37(4):649-53; discussion 653-4. doi: 10.1227/00006123-199510000-00007.
Results Reference
background
PubMed Identifier
20730474
Citation
Chen L, White WL, Spetzler RF, Xu B. A prospective study of nonfunctioning pituitary adenomas: presentation, management, and clinical outcome. J Neurooncol. 2011 Mar;102(1):129-38. doi: 10.1007/s11060-010-0302-x. Epub 2010 Aug 21.
Results Reference
background
PubMed Identifier
17236489
Citation
Zada G, Liu CY, Fishback D, Singer PA, Weiss MH. Recognition and management of delayed hyponatremia following transsphenoidal pituitary surgery. J Neurosurg. 2007 Jan;106(1):66-71. doi: 10.3171/jns.2007.106.1.66.
Results Reference
background
PubMed Identifier
22905890
Citation
Staiger RD, Sarnthein J, Wiesli P, Schmid C, Bernays RL. Prognostic factors for impaired plasma sodium homeostasis after transsphenoidal surgery. Br J Neurosurg. 2013 Feb;27(1):63-8. doi: 10.3109/02688697.2012.714013. Epub 2012 Aug 21.
Results Reference
background
PubMed Identifier
7616287
Citation
Kelly DF, Laws ER Jr, Fossett D. Delayed hyponatremia after transsphenoidal surgery for pituitary adenoma. Report of nine cases. J Neurosurg. 1995 Aug;83(2):363-7. doi: 10.3171/jns.1995.83.2.0363.
Results Reference
background
Learn more about this trial
Post-Operative Water Load Following Transsphenoidal Pituitary Surgery
We'll reach out to this number within 24 hrs