HUMAN ALBUMIN IN HEART FAILURE - DIORASIS TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Assessment of symptoms
研究概览
简要总结
Patients hospitalized for acute decompensation of CHF are usually complicated by worsening renal function (WRF) which leads to diuretic resistance and inadequate decongestion as well as poor prognosis. WRF has been attributed to a reflex renal vasoconstriction elicited by intravascular volume depletion during brisk diuresis. The investigators hypothesize that CHF patients with hepatic dysfunction are more prone to WRF due to poor albumin production. This sub-group of CHF patients may benefit more (increased diuretic efficacy and protected against worsening renal function) by the use of IV loop diuretics in combination with an intravascular volume expander such as IV Human Albumin.
详细描述
Acute decompensation of chronic heart failure (CHF) warranting hospital admission, defined as diagnosed on the basis of the presence of at least one symptom (dyspnea, orthopnea, paroxysmal nocturnal dyspnea, weight gain, worsening functional class or edema) and one sign (rales, peripheral edema, ascites, increased jugular vein pressure, hepatomegaly, third heart sound gallop or pulmonary vascular congestion on chest radiography) of heart failure plus laboratory or imaging evidence of hepatic dysfunction at randomization
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18 yrs
- •acute decompensation of CHF
- •evidence of hepatic dysfunction by laboratory biochemical measurements or imaging (liver ultrasonography)
- •history of CHF with previous use of an oral loop diuretic
- •anticipated need for IV diuretic therapy for at least 72 hours
- •There is no pre-specified inclusion criterion with respect to ejection fraction
排除标准
- •hemodynamic collapse (at least one of the following: systolic blood pressure (BP) < 90 mmHg, or BP drop by >= 40 mmHg for >= 15 min, with end-organ hypoperfusion; need for inotropes (except of digoxin); need for cardiopulmonary resuscitation).
- •hepatic dysfunction of other than cardiac etiology
- •severe anemia (Hb<8 g/dL)
- •uncontrolled hypertension or hypertensive emergency/urgency
- •pulmonary edema or pulmonary congestion necessitating use of IV vasodilators
- •serum creatinine > 3 mg/dL or glomerular filtration rate (GFR) < 30 ml/min
研究组 & 干预措施
IV Furosemide alone
Continuous slow IV infusion of Furosemide
干预措施: Human albumin (Drug)
IV Human Albumin + IV Furosemide
Continuous slow IV infusion of Human Albumin plus IV Furosemide
干预措施: Human albumin (Drug)
结局指标
主要结局
Assessment of symptoms
时间窗: From baseline to 72 hours.
Patient's global assessment of symptoms, measured with the use of a visual-analogue scale (VAS) and quantified as the area under the curve (AUC) of serial assessments.
Change in the serum creatinine level
时间窗: From baseline to 72 hours.
Change in the serum creatinine level
次要结局
- Patient-reported dyspnea(From baseline to 72 hours.)
- Changes in body weight(From baseline to 72 hours.)
- Length of stay(From baseline to discharge.)
- The composite of death, rehospitalization, escalation in treatment or an emergency room visit within 180 days.(From baseline to 180 days from discharge.)
- Net fluid loss(From baseline to 72 hours)
研究者
Marios-Vasileios Koutroulos
Cardiology Resident
Democritus University of Thrace