Intensive Management of Pressure and Volume Expansion in Patients With Subarachnoid Hemorrhage
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Our primary endpoint is to determine the feasibility of the pilot study within the ICU setting and collect preliminary estimates for sample size calculations.
研究概览
简要总结
The purpose of our study is to determine how well Triple-H works and how safe it is. The investigators are hoping to determine the effects of starting the therapy early and to explore if hypervolemia and/or hypertension are beneficial, and what the optimal target ranges are.
详细描述
Efficacy of Triple-H therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Age more than or equal to 18 years
- •Aneurysmal SAH of any clinical grade
- •Head computed tomography demonstrating SAH
- •Cerebral angiography revealing the presence of cerebral aneurysm(s) in a location that explains the SAH
- •Treatment of aneurysm with clipping or coiling must be carried out prior to randomization and within 72 hours of bleeding
- •Signed consent by study participant or applicable legal representative within 72 hours after SAH
排除标准
- •History of traumatic SAH
- •Non-aneurysmal SAH as indicated by no demonstrable aneurysm by cerebral angiography
- •Presence of an unsecured intracranial aneurysm(s) at risk of rupture that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- •Delayed referral with clipping/coiling greater than 72 hours after the initial bleeding
- •Time of symptom onset cannot be reliably determined
- •Intracranial hypertension (ICP >25 mm Hg) at the time of screening
- •History within the past six months and/or physical findings on admission of decompensated congestive heart failure (NYHA functional class III or IV, or objective class C or D)
- •Acute, evolving or recent myocardial infarction
- •Cardiac arrhythmia or second and third degree atrio-ventricular block causing hemodynamic instability
- •Chronic renal failure requiring dialysis
- •Suspected or confirmed pregnancy
- •Non English speaking
- •A condition that would preclude the performance of the neurobehavioral test battery due to a prior diagnosis of Alzheimer's disease, stroke, degenerative condition, cerebral tumor, or mental retardation
- •Severe terminal disease with life expectancy less than 6 months
- •Refusal of consent
结局指标
主要结局
Our primary endpoint is to determine the feasibility of the pilot study within the ICU setting and collect preliminary estimates for sample size calculations.
时间窗: 6 months
1. Estimation of the eligible population once specific study inclusion \& exclusion criteria are applied 2. Estimation of enrollment projections, retention, attrition \& losses to follow up; 3. Assessment of compliance with protocol instructions; 4. Evaluation of protocol violations; 5. Achievement of pre-determined hemodynamic goals in each study group.
次要结局
未报告次要终点
研究者
Miriam Treggiari
Professor
University of Washington