跳至主要内容
临床试验/NCT01630317
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

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

发起方
Parc de Salut Mar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nuria Ribas

Nuria Ribas

Parc de Salut Mar

研究点 (2)

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