Post-Operative Water Load Following Transsphenoidal Pituitary Surgery

November 21, 2019 updated by: Pam Dewey, St. Joseph's Hospital and Medical Center, Phoenix
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Brain and Spine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Water Load (WL) Post-Operative Day 1
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.
Other: Water Load (WL) Post-Operative Day 1
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
POD1 Response Serum Sodium
Time Frame: Post-Operative Day 1
Evaluate patients' responses to water load on the morning of post-operative day 1: serum sodium (normal range 135-145 mmol/L)
Post-Operative Day 1
POD1 Response Serum Osmolality
Time Frame: Post-Operative Day 1
Evaluate patients' responses to water load on the morning of post-operative day 1: serum osmolality (normal range 275-300 mOsm/kg)
Post-Operative Day 1
POD1 Response Urine Output
Time Frame: Post-Operative Day 1
Evaluate patients' responses to water load on the morning of post-operative day 1: urine output (normal range > 0.5 ml/kg/hr)
Post-Operative Day 1
POD1 Response Vasopressin
Time Frame: Post-Operative Day 1
Evaluate patients' responses to water load on the morning of post-operative day 1: vasopressin level (normal range 0.0 - 6.9 pg/ml)
Post-Operative Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Discharge Response
Time Frame: Post-Operative Day 2-7
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).
Post-Operative Day 2-7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Collaborators

Barrow Neurological Institute
Barrow Brain and Spine

Investigators

  • Principal Investigator: Andrew S Little, MD, Barrow Brain and Spine, Phoenix AZ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

December 13, 2018

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimate)

April 5, 2016

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHX1600103012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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