Hyponatremia Study (Delayed Hyponatremia After Pituitary Surgery)

  • STATUS
    Recruiting
  • days left to enroll
    89
  • participants needed
    200
  • sponsor
    Washington University School of Medicine
Updated on 23 April 2021
nausea
gonadotropin
fluid restriction
cyst
growth hormone
adenoma
hormone secreting
vomiting
headache
prolactin
ACTH
coma
pituitary adenoma
pituitary tumor
pituitary disorders

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.

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 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.

Details
Condition Surgery, Pituitary Gland, Pituitary Disease, Surgical aspects, Surgery, Pituitary Adenoma, Hyponatremia, Low Blood Sodium (Hyponatremia), Hyponatremic, Pituitary Disorders, pituitary tumor, pituitary, surgical procedures, surgical treatment, surgeries, surgical procedure
Treatment Fluid Restricted Group
Clinical Study IdentifierNCT03636568
SponsorWashington University School of Medicine
Last Modified on23 April 2021

Eligibility

Yes No Not Sure

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
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