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临床试验/NCT02640846
NCT02640846Unknown4 期

Potential Differences Between Levosimendan and Milrinone on Myocardial and Hemodynamic Variables in Patients With Septic Cardiomyopathy. Effects of Norepinephrine on Right Ventricular Function in Patient With Septic Shock.

Sahlgrenska University Hospital, Sweden1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
30
试验地点
1
主要终点
Changes in LV systolic strain

研究概览

简要总结

The aim of this study is to investigate the effects milrinon and levosimandan on n heart function in septic cardiomyopathy and how norepinephrine affects the left and right ventricular function in patients with septick shock using pulmonary artery catheter, conventional and strain echocardiography.

详细描述

This is a prospective study where 30 patients with septic chock during the care in ICU, will be included. Patients with a history of previous heart disease are excluded from the study. Each patient is in need of norepinephrine infusion and on mechanical ventilation. Initially the mean arterial pressure (MAP) is randomly changed from 60 to 75 and then to 90 mmHg. Hemodynamic variables as blood pressure, cardiac output, pulmonary artery occlusion pressure (PAOP) will be registerd at each MAP-level, arterial line and pulmonary artery catheter (PAC) and the cardiac function will be assessed with conventional and strain echocardiography. Then, if the echocardiogram shows impaired LV-function will the patient be randomized to receive either Milrinone or Levosimendan. Hemodynamic variables as blood pressure, cardiac output, pulmonary artery occlusion pressure (PAOP) will be registered again, as well the cardiac function with conventional and strain echocardiography. Echocardiograms will be analysed for the determination of LV an RV strain. Potential differences between different levels of blood pressure as well as effects of Milrinone or Levosimendan on hemodynamic and echocardiographyc variables will be analysed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Septic shock.
  • All patients will be resuscitated with fluids before the inclusion.
  • Need of Norepinephrine infusion.
  • Myocardial dysfunction in echocardiogram, either LVEF < 50% or Global Left Ventricular Systolic strain over -15%.

排除标准

  • History of previous heart disease or pulmonary hypertension.
  • Age < 18 years.
  • Cardiac arrhythmia.

研究组 & 干预措施

Milrinone

Active Comparator

Doser

干预措施: Milrinone (Drug)

Norepinephrine

Active Comparator

Doser

干预措施: Norepinephrine (Drug)

Levosimendan

Active Comparator

Doser

干预措施: Levosimendan (Drug)

结局指标

主要结局

Changes in LV systolic strain

时间窗: 1.5 hours

Changes in LV systolic function (global strain) will be assessed by 2D speckle tracking echocardiography

Changes in RV systolic strain

时间窗: 1.5 hours

Changes in RV systolic function (RV free wall strain) will be assessed by 2D speckle tracking echocardiography

次要结局

未报告次要终点

研究者

发起方
Sahlgrenska University Hospital, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Keti Dalla

MD

Sahlgrenska University Hospital, Sweden

研究点 (1)

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