The Effects of Glucocorticoids on Mortality and Renal Function in Patients With Acute Decompensated Heart Failure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Cardiovascular mortality in the 30 days following randomization.
研究概览
简要总结
Evidence showed that glucocorticoids could induce potent diuretic actions and improve renal functions in patients with decompensated congestive heart failure. Thus we design this study to determine the efficacy of glucocorticoids on cardiovascular mortality in the 30 days following randomization.
详细描述
Newly emerging clinical evidence showed glucocorticoids, when added to best conventional therapy, could produce potent diuretic effects, and improve renal functions in patients with decompensated congestive heart failure. It holds ture even in the patients who failed to respond to high dose of furosemide (>200mg/day). The present study is to confirm the clinical efficacy of glucocorticoids on cardiovascular mortality in patients with decompensated congestive heart failure who are on best conventional therapy.
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
- •Patients with dyspnea at rest due to acutely decompensated CHF requiring hospitalization and intravenous therapy. The cardiac etiology for acutely decompensated CHF was established by echocardiogram and/or a chest x-ray film and 2 of the following:
- •>2-pillow orthopnea before study entry
- •Jugular venous distention and/or abdominal discomfort due to mesenteric congestion.
- •Patients may have had acute decompensation of chronic heart failure, gradual worsening of chronic heart failure, or new onset of acutely decompensated CHF. Patients who were receiving intravenous therapy i.e. Inotropic and/or vasodilator but who otherwise met entry criteria were also permitted into the study. Patients with signs of cardiac shock were also permitted into the study.
排除标准
- •Patient refusal
- •Any signs of infection
- •any condition that would contraindicate a glucocorticoids use
- •Poor controlled hypertension
- •Poor controlled diabetes mellitus
- •Active myocarditis
- •Malignancy or other terminal illness
研究组 & 干预措施
glucocorticoid
干预措施: glucocorticoid (Drug)
Standard care
干预措施: standard care (Drug)
结局指标
主要结局
Cardiovascular mortality in the 30 days following randomization.
时间窗: 30 days following randomization
次要结局
- Renal function(on day 7)
- physician assessed global clinical status(on day 3 and day 7)
- patient assessed dyspnea(on day 3 and day 7.)
研究者
Kun-shen Liu M.D.
Professor
Hebei Medical University