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 : September 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hyponatremia Hyponatremic Pituitary Tumor Pituitary Surgery||Other: Fluid Restricted Group||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Early Fluid Restriction to Prevent Delayed Hyponatremia Following Pituitary Surgery|
|Actual Study Start Date :||June 2, 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2020|
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)
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:
No Intervention: Non Fluid Restricted
No fluid restriction
- Development of hyponatremia or low sodium [ Time Frame: 3-14 days after surgery ]Sodium level <135 mEq/L
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636568
|Contact: Traci Bell, BSNfirstname.lastname@example.org|
|Contact: Julie Silverstein, MDemail@example.com|
|United States, Missouri|
|Barnes Jewish Hospital||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Traci Bell, BSN|
|Principal Investigator:||Julie Silverstein, MD||Washington University School of Medicine|