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Hyponatremia Study (Delayed Hyponatremia After Pituitary Surgery) (DHAPS)

Primary Purpose

Hyponatremia, Hyponatremic, Pituitary Tumor

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluid Restricted Group
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyponatremia focused on measuring hyponatremia, hyponatremic, pituitary tumor, transsphenoidal resection, pituitary surgery, pituitary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Any adult patient with a pituitary adenoma or cyst (either non-functioning, prolactin-secreting, growth hormone secreting, ACTH (adrenocorticotropic hormone)-secreting, gonadotropin secreting, or TSH secreting) scheduled to undergo pituitary resection.

Exclusion Criteria:

  • Patients with a history of chronic hyponatremia
  • Patients with a history of SIADH (syndrome of inappropriate antidiuretic hormone) , except if secondary to hypothyroidism or adrenal insufficiency, or in association with prior TSS
  • Patients with diabetes insipidus or patients receiving DDAVP
  • Patients without an intact thirst mechanism
  • Patients with CKD (chronic kidney disease) stage III, IV or V
  • Patients with untreated adrenal insufficiency or hypothyroidism
  • Patients with class III or IV heart failure

Sites / Locations

  • Barnes Jewish Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fluid restricted

Non Fluid Restricted

Arm Description

Fluids will be stopped at 8am on POD 1 and patients will be started on a moderate fluid restriction on POD #3 based on their weight (1000 cc/24 hours for patients who weigh <=100 kg and 1200 cc/24 hours for patients who weigh > 100kg)

No fluid restriction

Outcomes

Primary Outcome Measures

Development of hyponatremia or low sodium
Sodium level <135 mEq/L

Secondary Outcome Measures

Full Information

First Posted
August 1, 2018
Last Updated
April 20, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03636568
Brief Title
Hyponatremia Study (Delayed Hyponatremia After Pituitary Surgery)
Acronym
DHAPS
Official Title
Early Fluid Restriction to Prevent Delayed Hyponatremia Following Pituitary Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2, 2016 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hyponatremia is defined as sodium below the normal range of 135-145. Symptomatically, it can cause patients to experience a wide range of symptoms including lethargy, headache, nausea, vomiting and in severe cases coma and even death. The goal of this study is to prospectively compare two approaches to the postoperative fluid management of patients undergoing transsphenoidal resection of a pituitary tumor or cyst to decrease the occurrence of postoperative delayed hyponatremia. One group will be placed on moderate fluid restriction and the other group will be placed on ad lib fluid intake.
Detailed Description
Any adult patient with a pituitary adenoma (either non-functioning, prolactin-secreting, growth hormone secreting, gonadotropin secreting, or TSH (thyroid stimulating hormone) secreting) or cyst scheduled to undergo transsphenoidal resection will be included in the study. Patients with chronic hyponatremia will be excluded. Patients will be randomly assigned to one of two groups: Group 1: these patients will be treated with moderate fluid restriction (1000 ml/24 hours for patients <100kg and 1200 ml of fluid/24 hours for >100 kg starting on postoperative day 1. Fluid restriction will be aborted if diabetes insipidus occurs. Diabetes insipidus occurs if a patient does not produce enough ADH (anti-diuretic hormone) which is needed to concentrate the urine. Diabetes insipidus causes increased urination and increased thirst and can cause hypernatremia (an increased sodium level). A person will be diagnosed with diabetes insipidus if they meet all of the following criteria: serum sodium level > 146, dilute urine with a urine specific gravity < 1.003 and increased urine output defined by urine output > 300cc/hour for 2 consecutive hours( or > 6 liter/24 hours). Group 2: these patients will not be placed on fluid restriction, they will be allowed to drink water freely after surgery. All patients will be started on D5 ½ normal saline IV fluids (Weight based) and will be allowed to eat and drink starting on POD 1. All the patients will receive a thirst questionnaire that will be completed daily starting on POD 1 until POD 13. The intensity of thirst will be assessed on a scale of 1--10, with 1 being no thirst, 5 being normal thirst and 10 being unbearable thirst. Patients will have basic metabolic panels checked on post-surgical days 1, 3, 7, 10 and 13.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyponatremia, Hyponatremic, Pituitary Tumor, Pituitary, Surgery
Keywords
hyponatremia, hyponatremic, pituitary tumor, transsphenoidal resection, pituitary surgery, pituitary

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluid restricted
Arm Type
Experimental
Arm Description
Fluids will be stopped at 8am on POD 1 and patients will be started on a moderate fluid restriction on POD #3 based on their weight (1000 cc/24 hours for patients who weigh <=100 kg and 1200 cc/24 hours for patients who weigh > 100kg)
Arm Title
Non Fluid Restricted
Arm Type
No Intervention
Arm Description
No fluid restriction
Intervention Type
Other
Intervention Name(s)
Fluid Restricted Group
Intervention Description
Patients will be started on a weight-based intravenous fluid replacement with D5 ½ NS on POD 0 (75 cc/hr for patients < 70kg, 100 cc/hr for patients 70-100kg, and 125 cc/hr for patients >100kg). Patients will be allowed to drink water freely after surgery on POD #0. Fluids will be stopped at 8am on POD 1 and patients will be started on a moderate fluid restriction on POD #3 based on their weight (1000 cc/24 hours for patients who weigh <=100 kg and 1200 cc/24 hours for patients who weigh > 100kg). Prior to initiation of a fluid restriction all of the following criteria have to be met: Serum Na level must be < 145 mEq/l Patient should be taking fluids by mouth Patient should not have evidence of DI (as determined by endocrine team following patient) If a patient in Fluid Restricted group develops DI, the fluid restriction will be stopped/not initiated.
Primary Outcome Measure Information:
Title
Development of hyponatremia or low sodium
Description
Sodium level <135 mEq/L
Time Frame
3-14 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Any adult patient with a pituitary adenoma or cyst (either non-functioning, prolactin-secreting, growth hormone secreting, ACTH (adrenocorticotropic hormone)-secreting, gonadotropin secreting, or TSH secreting) scheduled to undergo pituitary resection. Exclusion Criteria: Patients with a history of chronic hyponatremia Patients with a history of SIADH (syndrome of inappropriate antidiuretic hormone) , except if secondary to hypothyroidism or adrenal insufficiency, or in association with prior TSS Patients with diabetes insipidus or patients receiving DDAVP Patients without an intact thirst mechanism Patients with CKD (chronic kidney disease) stage III, IV or V Patients with untreated adrenal insufficiency or hypothyroidism Patients with class III or IV heart failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Silverstein, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Hyponatremia Study (Delayed Hyponatremia After Pituitary Surgery)

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