Hyponatremia Study (Delayed Hyponatremia After Pituitary Surgery)
关键词
抽象
描述
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.
日期
| 最后验证: | 06/30/2020 |
| 首次提交: | 07/31/2018 |
| 提交的预估入学人数: | 08/14/2018 |
| 首次发布: | 08/16/2018 |
| 上次提交的更新: | 07/13/2020 |
| 最近更新发布: | 07/15/2020 |
| 实际学习开始日期: | 06/01/2016 |
| 预计主要完成日期: | 11/30/2020 |
| 预计完成日期: | 11/30/2020 |
状况或疾病
干预/治疗
Other: Fluid restricted
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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 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. |
| No Intervention: Non Fluid Restricted No fluid restriction |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. Development of hyponatremia or low sodium [3-14 days after surgery]
