Furosemide Treatment Before Blood Transfusion in Patients With Systolic Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Diastolic echocardiographic changes following blood transfusion, with or without Furosemide treatment
研究概览
简要总结
The study Objective is to assess the clinical and echocardiographic changes of patients with systolic dysfunction receiving blood transfusion, with or without prior treatment with furosemide
详细描述
More than 4 million patients receive a blood transfusion each year in the United States, many of them suffer from congestive heart failure. The reported prevalence of anemia in CHF is unknown, ranges widely from 4% to 70%, due to a lack of an established, consistent definition of anemia in CHF.
Treating CHF patients with furosemide prior to blood transfusion became a common practice, even though no randomize clinical trial had examine this issue. Nand et al. measured the pulmonary capillary wedge pressures in 20 adults with chronic severe anemia (Hg <6 mg/dl) and no systemic disease before and after transfusion of 700ml of whole blood. Ten of these patients were treated with furosemide (40 mg intra-venous) immediately prior the transfusion. The PCWP had increased significantly among patient who did not receive the furosemide and decreased by 3.75% among patients in the furosemide group, although this change was not was statistically significant. In another study, the same group of Nand et al. measured the PCWP among 40 chronic anemia patients receiving blood transfusion. None of the patients suffered from cardiopulmonary disease. The patients were randomly divided into 4 groups: the difference between the first 3 groups was the speed of the transfusion (2 ml/min, 5 ml/min and 10 ml/min). The fourth group patients were treated with 40 mg of furosemide before the transfusion was given in a rate of 5 ml/min. The PCWP increased significantly in the first 3 groups, with the rise being proportionately greater with faster transfusions (15.8, 20.9 and 32.2% in groups A, B and C, respectively). In the furosemide group, however, the PCWP decreased significantly by 21.7%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is over 18 years old.
- •Documented ejection function equal to or over 40% in prior tests
- •The treating physician decided to treat the patient with packed cell
排除标准
- •Known hypersensitivity to furosemide.
- •Calculated creatinine clearance over 20% (by MDRD)
- •Past adverse reaction to blood product.
研究组 & 干预措施
arm1
will receive 60 mg (6 ml) of intra-venous furosemide before administration of the blood transfusion (250-300 ml of packed cells).
干预措施: furosemide (Drug)
arm2
will receive 6 ml of normal saline (NaCl 0.9%) before administration of the blood transfusion (250-300 ml of packed cells).
干预措施: placebo normal saline (Drug)
结局指标
主要结局
Diastolic echocardiographic changes following blood transfusion, with or without Furosemide treatment
时间窗: Within 4 hours from receiving the blood transfusion
Diastolic echocardiographic variables, including Ea, E to Ea ratio, E to A ratio, and Pulmonary vein flow velocities, following blood transfusion, with or without Furosemide treatment
次要结局
- clinical outcome following blood transfusion, with or without Furosemide treatment(Within 4 hours from receiving the blood transfusion)
