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临床试验/EUCTR2021-005551-36-DK
EUCTR2021-005551-36-DK进行中(未招募)1 期

Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients with Cardiogenic Shock from Acute Myocardial Infarction: A Multicenter Randomized Trial - NORSHOCK

Amsterdam University Medical Center, AMC0 个研究点目标入组 776 人开始时间: 2023年2月28日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
776

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Acute myocardial infarction, STEMI or NSTEMI
  • 2. Early revascularization by PCI
  • 3. Cardiogenic shock, characterized by:
  • I. Signs of impaired organ perfusion with at least one of the following criteria:
  • a. Altered mental status
  • b. Cold, clammy skin and extremities
  • c. Oliguria with urine output < 30ml/hour
  • d. Serum lactate > 2.0 mmol/L
  • II. a. Systolic blood pressure (SBP) < 90 mmHg for > 30 minutes, OR
  • b. Use of drugs to maintain SBP > 90 mmHg at presentation before randomization.
  • III. Clinical signs of pulmonary congestion
  • 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 276
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 500

排除标准

  • -Resuscitation > 30 minutes
  • - Mechanical cause of cardiogenic shock (e.g. papillary muscle rupture, ventricular septal rupture)
  • - Onset of shock > 12 hours
  • - Imminent need for mechanical circulatory support
  • -Women < 45 years

研究者

发起方
Amsterdam University Medical Center, AMC

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