跳至主要内容
临床试验/NCT00279214
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

Eli Lilly and Company3 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2005年11月最近更新:
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
3
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

入选标准

  • 未提供

排除标准

  • 未提供

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

  • Lactate Level(Baseline to 6 Hours)
  • Cardiovascular Performance Measures Obtained With a Pulmonary Artery Catheter - Cardiac Index(Baseline to 24 Hours)
  • Change From Baseline to 96 Hour Endpoint in Cumulative Vasopressor Index (CVI)(Baseline, 96 hours)
  • Mean Arterial Pressure(baseline to 24 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

申办方类型
Industry

研究点 (3)

Loading locations...

相似试验