Post-Operative Water Load Following Transsphenoidal Pituitary Surgery
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Brain Cancer, Metabolic |
| Therapuetic Areas: | Oncology, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 8/17/2018 |
| Start Date: | March 7, 2016 |
| End Date: | January 2019 |
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.
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.
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.
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.
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
We found this trial at
1
site
Phoenix, Arizona 85013
Principal Investigator: Andrew S Little, MD
Phone: 602-406-6976
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