Use of Conivaptan (Vaprisol) for Hyponatremic Neuro-ICU Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 6
- 主要终点
- Change in Serum Sodium From Baseline to 6 Hours
研究概览
简要总结
Conivaptan (Vaprisol) is FDA-Approved for the treatment of low serum sodium (hyponatremia), but there are few data in patients with neurologic disease. Very low serum sodium in patients with brain injury can be life-threatening and is associated with cerebral edema (swelling of brain tissue). This can be important in patients with brain hemorrhage, brain tumors, or stroke (cerebral infarction).
This is a pilot study to test the hypothesis that conivaptan (Vaprisol) leads to a greater increase in sodium than usual care. Patients will be randomly assigned to usual care or the lower FDA-approved dose of conivaptan (Vaprisol). We will track the use of other interventions, such as the use of hypertonic saline (concentrated salt solution), diuretics and salt tablets. A blinded co-investigator will record neurologic examination results (NIH Stroke Scale and Glasgow Coma Scale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe hyponatremia (Na < 130 mmol/L) or
- •symptomatic hyponatremia - Na < 135 mmol/L for at least six hours with Glasgow Coma Scale < 15
排除标准
- •Enrollment in the NMH high-risk spine protocol. These patients receive large amounts of fluids, have rapid changes in electrolytes, and are typically corrected in 48 hours
- •Expected death from any cause
- •Known sensitivity or allergy to conivaptan
- •Renal failure (baseline creatinine > 1.5 mg/dL)
- •Clinical diagnosis of hypovolemia, or by central venous pressure (CVP) < 5 mm Hg if a central venous catheter is in place
- •Concomitant use of potent inhibitors of cytochrome P-450 isoenzyme 3A4 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir). These agents are not commonly used in the Neuro-ICU
- •Clinical diagnosis of liver failure or insufficiency
- •Pregnancy (must be excluded before entry)
- •Lack of informed consent from the patient or a legally authorized representative (LAR)
- •Use of intra-arterial vasodilators (e.g. verapamil, nicardipine) within 24 hours (e.g. for vasospasm after SAH)
- •Concern by the Neuro-ICU pharmacist of a drug-drug interaction that would meaningfully impact care (the Neuro-ICU pharmacist will review the medication regimen before recruitment)
- •Patients with a diagnosis of diabetes insipidus or treated with vasopressin, since these patients are already treated for abnormal free water balance
- •Patients with congestive heart failure, since this is an approved use of the drug (these patients are typically not cared for in the Neuro-ICU)
- •Age<18 years (these patients are not cared for at NMH)
- •Inclusion declined by the attending physician or consulting study nephrologist
研究组 & 干预措施
1
Conivaptan in addition to usual care at the discretion of the attending medical staff
干预措施: Conivaptan (Drug)
结局指标
主要结局
Change in Serum Sodium From Baseline to 6 Hours
时间窗: 48 hours
次要结局
- NIH Stroke Scale(48 hours)
- Glasgow Coma Scale(48 hours)
研究者
Andrew Naidech
Associate Professor
Northwestern University