NCT00279214已完成4 期
An Evaluation of Vasopressor Requirement, Hemodynamic Response and Measures of Tissue Perfusion With the Administration of Drotrecogin Alfa (Activated) as Part of Physician-Directed Therapy in Patients With Septic Shock
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Cumulative Vasopressor Index (CVI)
研究概览
简要总结
The study will evaluate the vasopressor requirement, hemodynamic response and measures of tissue perfusion in patients with septic shock receiving an infusion of drotrecogin alfa (activated) compared to patients not receiving drotrecogin alfa (activated).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •18 years of age or older with a diagnosis of septic shock
- •presence of a pulmonary artery catheter (or central venous catheters)
- •requiring vasopressor support despite adequate fluid resuscitation
- •an intravenous steroid administered for septic shock, except for those patients who were tested and are responders to a corticotropin stimulation test, or patients who do not receive a steroid due to the clinical judgment of the treating physician, based on an alternate assessment (e.g. normal baseline cortisol).
排除标准
- •Onset of first-sepsis induced organ dysfunction is greater than 24 hours from the time of informed consent
- •Baseline measurements of pulmonary artery occlusive pressure (PAOP) < 12 mmHg or a central venous pressure (CVP) < 8 mmHg
- •Patient requires continuous oxygen therapy by face-mask
- •The presence of an advanced directive to withhold life-sustaining treatment, with the exception of a directive to withhold chest compressions only
- •Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- •Weight > 200 kg
- •Are moribund (not expected to survive 24 hours)
- •Are pregnant or are lactating and the milk is to be ingested by the infant (pregnancy status must be verified by urine or serum testing)
- •Have not completed written informed consent signed by the patient or the patient's legal representative.
结局指标
主要结局
Cumulative Vasopressor Index (CVI)
时间窗: baseline to 24 hours
CVI is sum of rankings for all vasopressors being used by patient at given time. Based on relative potency and dosing range for each vasopressor, each vasopressor was assigned ranking of 1 (low dosage) to 4 (high dosage). Range of CVI is between 1 and 20.
次要结局
- Change From Baseline to 96 Hour Endpoint in Cumulative Vasopressor Index (CVI)(Baseline, 96 hours)
- Mean Arterial Pressure(baseline to 24 hours)
- Cardiovascular Performance Measures Obtained With a Pulmonary Artery Catheter - Cardiac Index(Baseline to 24 Hours)
- Lactate Level(Baseline to 6 Hours)
- Microcirculatory Measures From Sidestream Darkfield (SDF) Microscopy - Small Vessel Microvascular Flow Index (MFI)(Baseline to 24 Hours)
- Sequential Organ Failure Assessment (SOFA) Score at Baseline and 24 Hours(Baseline and 24 Hours)
- Change From Baseline in Creatinine Clearance (CrCl) at 24 Hours(Baseline and 24 hours)
- 7 Day All-cause In-hospital Mortality(baseline to 7 days)
- Endogenous Protein C Level(Baseline to 24 Hours)
- Mixed Venous Oxygen Saturation(Baseline to 24 Hours)
研究者
研究点 (2)
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