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临床试验/EUCTR2009-014769-16-IT
EUCTR2009-014769-16-IT进行中(未招募)不适用

REWORD-HF REverse WOrsening Renal function in Decompensated Heart Failure Impact of different therapeutic approaches in patients with cardiorenal syndrome in the setting of acute decompensated congestive heart failure (ADCHF) - REWORD-HF

AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA` GRANDA (A.O. DI RILIEVO NAZIONALE)0 个研究点开始时间: 2009年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Informed consent On admission - Age 18-80 years - NYHA class III IV - Signs of pulmonary (pulmonary rales, and interstitial oedema or pleural effusion on chest Xray) and/or systemic congestion (pitting ankle oedema and enlarged liver or ascites and neck vein distension ≥ 7 cm) and weight gain ≥ 2 kg during the previous week - Glomerular filtration rate ≥ 30 ml/min - BNP increased >400 pg/ml (diagnostic cut-off for ADCHF), as confirmatory diagnostic test28 24 hours after admission (randomization) - Persistents signs of pulmonary (pulmonary rales, interstitial oedema or pleural effusion on chest Xray) and/or systemic congestion (ankle oedema, enlarged liver or ascites, neck vein distension ≥ 7 cm) - Serum creatinine or urine output criteria indicative of modified RIFLE (AKI: risk) class at least 1 (increase x 1.5 in serum creatinine or decrease > 25% in GFR or urine output < 0.5 ml/Kg/h for more than 6 hours) 29-30 during diuretic infusion
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Chronic kidney disease stage 4-5 (GFR < 30 ml/min) - Acute coronary syndromes - Systolic blood pressure <90 mm Hg/need for intravenous inotropes - Hematocrit > 45% - Unattainable venous access - Contraindications to anticoagulation by heparin - Systemic infection - Heart transplant

研究者

发起方
AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA` GRANDA (A.O. DI RILIEVO NAZIONALE)

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