NCT00420407终止早期 1 期
Prospective, Randomized, Double-Blind, Multi-Center Trial of Low Dose Vasopressin Versus Placebo in Traumatic Shock Resuscitation
The University of Texas Health Science Center at San Antonio1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2007年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- The Primary Endpoint of This Study Will be Day 30 Mortality.
研究概览
简要总结
Hypothesis: We hypothesize that resuscitation regimens which minimize the total volume of resuscitation fluid, while restoring organ perfusion, will lead to lower morbidity and mortality in critically ill patients following trauma.
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
- Triple (Participant, Care Provider, Investigator)
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
- •To be eligible for enrollment in the study, a patient must meet all of the follow criteria at assessment:
- •Patient is a male or female patient presumed to be at least 18 years of age;
- •Patient has a systolic blood pressure < 90 mmHg;
- •Patient has clinical evidence of acute traumatic injury;
- •Infusion of study drug must start within one hour following SBP (systolic blood pressure) < 90 mmHg
排除标准
- •A patient meeting any one of the following criteria at hospital assessment is not eligible for enrollment:
- •Patient is admitted to one of the study hospitals' Emergency Department greater than six hours after injury;
- •Patient has received greater than 4 liters fluid since time of injury;
- •Patient is enrolled in another shock trial;
- •Patient is asystolic or requires CPR (cardiopulmonary resucitation) prior to randomization;
- •Female patient is pregnant by report or suspicion;
- •Patient has known "Do Not Resuscitate" orders or visible/identifiable method of objection to participation (e.g., exclusion bracelet);
研究组 & 干预措施
I
Experimental
Vasopressin
干预措施: vasopressin (Drug)
2
Placebo Comparator
bolus of NS (normal saline) followed by continuous infusion of NS, no vasopressin added
干预措施: normal saline control (Drug)
结局指标
主要结局
The Primary Endpoint of This Study Will be Day 30 Mortality.
时间窗: 30 days
Survival of a traumatic injury subject to at least 30 days after admission to the emergency room.
次要结局
- Level of Vasopressin After Trauma.(12 hours)
研究者
研究点 (1)
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