Low-chloride Versus High-chloride Containing Hypertonic Solution for the Treatment of Subarachnoid Hemorrhage-Related Complications
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Difference between serum chloride level on randomization day and the peak afterwards
研究概览
简要总结
This pilot study will compare the two hypertonic solutions currently used for subarachnoid hemorrhage (SAH) - related complications and to determine if the reduction of chloride load is safer, and as efficacious as the classic hypertonic solution.
详细描述
This pilot study aimed to collect high-quality randomized and prospective information to help plan a future, larger multicenter trial. The study will compare the two hypertonic solutions currently used for subarachnoid hemorrhage (SAH) - related complications and to determine if the reduction of chloride load by using a sodium acetate and sodium chloride mixture can lead to a relative reduction of serum chloride, reduce kidney injury, and as efficacious as the classic hypertonic solution.
Hyperosmolar therapy is one of the mainstay treatments for SAH-related cerebral edema and vasospasm, in order to reduce delayed cerebral ischemia. Recent evidence from the literature correlates high chloride load when applying IV fluids with worse outcome in a variety of critically-ill patients. Hypertonic saline, with which most hyperosmolar treatment is done, contains a supra-physiologic chloride load. It is possible that by changing the hypertonic solution to a "chloride-lean" one, the study team would be able to reduce the side effects of hypertonic sodium-chloride without losing its efficacy in treating SAH-related complications.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A double-blinded-double-dummy design, where each dose of hypertonic solution will be administered along with a balanced solution in order to mask the difference in the volume between the two solutions.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spontaneous SAH with an identified aneurysmal source as identified on neuroimaging obtained at admission to Emory University Hospital or with imaging at an outside hospital
- •Age ≥ 18 years
排除标准
- •SAH related to non-aneurysmal vascular anomaly
- •SAH thought due to trauma
- •SAH occurring in relation to another medical procedure (cardiac catheterization, LVAD placement, etc.)
- •SAH with a negative workup for cause ("angio-negative")
- •Patients who arrive in a brain-death state or in a devastating clinical status that will be presumed to lead to brain death or early withdrawal of treatment
- •Patient who suffer from end-stage renal disease at baseline and who are routinely treated with dialysis
- •Known pregnancy
研究组 & 干预措施
Sodium chloride /sodium acetate (16.4%)
50cc doses of sodium-chloride/sodium-acetate (16.4%) along with 30cc bag of dummy solution (PlasmaLyte).
干预措施: Sodium chloride /sodium acetate (16.4%) (Drug)
Sodium chloride /sodium acetate (16.4%)
50cc doses of sodium-chloride/sodium-acetate (16.4%) along with 30cc bag of dummy solution (PlasmaLyte).
干预措施: PlasmaLyte (Drug)
Sodium chloride (23.4%)
30cc per dose of sodium chloride (23.4%) along with 50cc dummy solution bag (PlasmaLyte)
干预措施: Sodium chloride (23.4%) (Drug)
Sodium chloride (23.4%)
30cc per dose of sodium chloride (23.4%) along with 50cc dummy solution bag (PlasmaLyte)
干预措施: PlasmaLyte (Drug)
结局指标
主要结局
Difference between serum chloride level on randomization day and the peak afterwards
时间窗: Baseline, up to once daily during a patient's stay in the ICU, and up to 90 days
Serum chloride levels will be measured as part of standard of care. Difference between serum chloride level on randomization day and the peak afterwards will be calculated.
次要结局
- All causes of in-hospital mortality.(Patients' stay in the ICU, and up to 90 days)
- All causes of 90 day mortality.(Up to 90 days)
- Number of patients with acute kidney injury (AKI)(Patients' stay in the ICU, and up to 90 days)
- Change in intracerebral pressure (ICP) measured by ICP monitor following hypertonic treatment.(Continuous measurement as long as the patient has an indication for an ICP monitor, and up to 90 days)
- Change in serum sodium level following the administration of the hypertonic solution.(Baseline, and daily during a patient's stay in the ICU, and up to 90 days)
研究者
Owen Samuels
Associate Professor
Emory University