NCT01718613已完成3 期
Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients
Instituto do Cancer do Estado de São Paulo1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- 28-day mortality
研究概览
简要总结
Although arginine vasopressin has been used as an additional drug in refractory shock in worldwide clinical practice, there are no prospective studies using it as a first choice therapy in patients with cancer and septic shock.
The aim of this study is assess if the use of arginine vasopressin would be more effective on treatment of septic shock in cancer patients than norepinephrine, decreasing the composite end point of mortality and organ failure in 28 days.
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)
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
- •Solid neoplasm needing ICU
- •Septic Shock according standard criteria
排除标准
- •Younger than 18 years;
- •Pregnancy;
- •Raynaud's phenomenon, systemic sclerosis or vasospastic diathesis;
- •Severe hyponatremia (Na<130mEq/L);
- •Acute mesenteric ischemia;
- •Acute myocardial infarction;
- •Cardiogenic shock;
- •Current use of vasopressor before randomization
- •Expected ICU stay less than 24 hours
- •Enrolled in another study;
- •Refusal to consent.
研究组 & 干预措施
Norepinephrine
Active Comparator
干预措施: Norepinephrine (Drug)
Vasopressin
Active Comparator
干预措施: Vasopressin (Drug)
结局指标
主要结局
28-day mortality
时间窗: 28-day from randomization
Mortality from all causes in 28-day follow-up
次要结局
- 90-days mortality(90 days after randomization)
- Days alive and free of renal replacement therapy(28 days after randomization)
- SOFA score in 24 hours(24 hours after ICU admission)
- SOFA score in 96 hours(96 hours after randomization)
- Days alive and free of mechanical ventilation(28 days after randomization)
- Days alive and free of vasopressors(28 days after randomization)
研究者
Cristiane Maciel Zambolim
Principal Investigator
Instituto do Cancer do Estado de São Paulo
研究点 (1)
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