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

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ClinicalTrials.gov Identifier: NCT03636568
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE August 1, 2018
First Posted Date  ICMJE August 17, 2018
Last Update Posted Date April 14, 2021
Actual Study Start Date  ICMJE June 2, 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2018)
Development of hyponatremia or low sodium [ Time Frame: 3-14 days after surgery ]
Sodium level <135 mEq/L
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyponatremia Study (Delayed Hyponatremia After Pituitary Surgery)
Official Title  ICMJE Early Fluid Restriction to Prevent Delayed Hyponatremia Following Pituitary Surgery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Hyponatremia
  • Hyponatremic
  • Pituitary Tumor
  • Pituitary
  • Surgery
Intervention  ICMJE Other: Fluid Restricted Group

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:

  1. Serum Na level must be < 145 mEq/l
  2. Patient should be taking fluids by mouth
  3. 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.
Study Arms  ICMJE
  • Experimental: Fluid restricted
    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)
    Intervention: Other: Fluid Restricted Group
  • No Intervention: Non Fluid Restricted
    No fluid restriction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 15, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Traci Bell, BSN 314-747-5371 traci.bell@wustl.edu
Contact: Julie Silverstein, MD 314-747-7006 jsilverstein@wustl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03636568
Other Study ID Numbers  ICMJE 16-05023
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julie Silverstein, MD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP