NCT01630317Unknown不适用
Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.
Parc de Salut Mar2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2011年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Efficacy
研究概览
简要总结
Slow continuous ultrafiltration using central vs peripheral line: feasibility of implementation, safety and efficacy in acute heart failure syndromes.
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
- 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
- •Patients hospitalized with primary diagnosis of acute heart failure defined as ≥ 2 of the following criteria:
- •Peripheral or sacral edema
- •Jugular venous distension or venous central pressure > 10 mmHg
- •Hepatomegaly or ascites
- •Pulmonary edema or pleural effusion on x-ray or pulmonary wedge pressure or end-diastolic pressure > 20 mmHg.
- •High pro-BNP
- •Randomization during first 24 hours
- •Serum creatinine levels < 3mg/dL, and K < 6 mmol/L
- •The patient should be able to communicate with research staff and meet with study procedures.
- •The patient will signed informed consent.
排除标准
- •Diagnosis of severe aortic stenosis or severe obstruction to the LVOT, tamponade, cardiac hypertrophic or restrictive cardiomyopathy.
- •Impossibility of venous catheterization
- •Acute coronary syndrome
- •Creatinine greater than 3.0 or K greater than 6 mmol/L.
- •Systolic blood pressure less than or equal to 100 mmHg
- •Hematocrit greater than 45%
- •Prior administration of IV vasoactive drugs in the emergency room (ER)
- •Clinical instability requiring pressors during hospitalization
- •On or requires renal dialysis.
结局指标
主要结局
Efficacy
时间窗: 48 hours after initiation of scuf therapy
Compare patient global improvement 48 hours after initiation of scuf therapy in a group of patients with the same features treated by peripheral access against a group of patients with the same features treated by central access. This outcome will be measured by patient global assessment
次要结局
- Security(5th day of the study)
研究者
Nuria Ribas
Nuria Ribas
Parc de Salut Mar
研究点 (2)
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