CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Water Load (WL) Post-Operative Day 1other
Likely dose
Not stated in record
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Search/NCT02727686
NCT02727686N/ACompleted

Post-Operative Water Load Following Transsphenoidal Pituitary Surgery

St. Joseph's Hospital and Medical Center, Phoenix·interventional·Posted Apr 5, 2016·Updated Nov 25, 2019

In Brief

A clinical study evaluating Water Load (WL) Post-Operative Day 1 for Hyponatremia and Pituitary Adenoma. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 5, 2016
Enrollment StartMar 7, 2016
Primary CompletionMar 1, 2018
Study CompletionDec 13, 2018
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 10.2 years ago

Interventions

Water Load (WL) Post-Operative Day 1other

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.