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临床试验/NCT06078436
NCT06078436招募中不适用

Pulmonary Artery Catheterization and Carvedilol Early Initiation in Cardiogenic SHOCK Caused by Heart Failure With Reduced Ejection Fraction

Min-Seok Kim2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年1月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
160
试验地点
2
主要终点
30-day all-cause mortality

研究概览

简要总结

This study aims to compare the impact of hemodynamic monitoring using pulmonary artery catheter (PAC) on survival and inotropic agent reduction in patients with cardiogenic shock caused by heart failure with reduced ejection fraction (HFrEF). The investigators also intend to compare the difference in long-term survival rates among patients who have recovered from cardiogenic shock due to HFrEF, based on the timing of initiation of beta-blocker treatment.

详细描述

Cardiogenic shock is one of the most common causes of shock patients admitted to the Cardiac Intensive Care Unit (CICU). Despite advances in treatment, the mortality rate of cardiogenic shock remains high, up to 50%, and improving survival is crucial through the use of inotropic agents, vasopressors, or mechanical circulatory support devices to improve hemodynamic parameters. Previous meta-analyses of retrospective studies have shown the usefulness of pulmonary artery catheter monitoring, especially in patients with cardiogenic shock due to heart failure. However, there is a lack of prospective studies regarding specific monitoring indicators and treatment goals. This study aims to compare the impact of hemodynamic monitoring through pulmonary artery catheter on survival and inotropic agent reduction in patients with cardiogenic shock caused by heart failure with reduced ejection fraction.

In the PAC non-monitoring group, various assessments such as physical examination, echocardiographic findings, serum lactate levels, chest x-ray, and laboratory test results are utilized. If there are signs of volume overload, diuretics or hemodialysis may be applied to achieve for volume reduction. The dosage of diuretics and the timing of hemodialysis are at the discretion of the attending physician. The target of a mean arterial pressure (MAP) is 65mmHg or higher. If the MAP falls below 65mmHg, increasing vasopressor or inotropes should be considered. If the MAP target is not achieved with medical therapy or if serum lactate levels increase by 3 mmol/L or more compared to the lowest value within 24 hours, mechanical circulatory support (MCS) is considered. The specific dosage of vasopressors/inotropes and the timing of MCS application are at the dscretion of the attending physician.

The PAC monitoring group, in addition to those used in the PAC non-monitoring group, treats patients using indicators measured by PAC. The targets include a right atrial pressure (RAP) or central venous pressure (CVP) of 8mmHg or lower and pulmonary capillary wedge pressure (PCWP) of 15mmHg or lower. Whan RAP or CVP exceeds 8mmHg, or PCWP exceeds 15mmHg, employing diuretics or hemodialysis should be considered for volume reduction. The dosage of diuretics and the timing of hemodialysis are at the discretion of the attending physician. The target of a mean arterial pressure (MAP) is 65mmHg or higher. If the MAP falls below 65mmHg, increasing vasopressor or inotropes should be considered. If the MAP target is not achieved with medical therapy or if serum lactate levels increase by 3 mmol/L or more compared to the lowest value within 24 hours, mechanical circulatory support (MCS) is considered. The specific dosage of vasopressors/inotropes and the timing of MCS application are at the dscretion of the attending physician.

Additionally, the beta-blocker Carvedilol is known to reduce mortality and readmission rates in heart failure patients based on large-scale clinical trials and is widely prescribed as a standard treatment. However, the evidence for the appropriate timing of Carvedilol initiation and objective indicators of hemodynamic stability beyond the point of discharge is currently insufficient, relying solely on the clinical judgment and experience of the treating physician. Through subgroup analysis, the investigators intend to compare the difference in long-term survival rates among patients who have recovered from cardiogenic shock due to heart failure with reduced ejection fraction, based on the timing of iniation of beta-blocker treatment. The early administration of Carvedilol is defined as initiating treatment within 24 to 48 hours after discontinuing vasopressor/inotropic agents or mechanical circulatory support in stable condition following cardiogenic shock. The conservative administration of Carvedilol is defined as initiating treatment at least 48 hours after discontinuing vasopressors/inotropic agents or mechanical circulatory support in stable condition following cardiogenic shock.

Also, lung B-line will be measure along with PAC measured hemodynamic parameters using lung ultrasound at eight regions of the thorax in patients with PAC monitoring. Number of B-line in a total and each region, positive region which is defined as having three or more number of B-line will be recorded. Acquired images will be adjudicated by two investigators who are blinded to the clinical information of the subject.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults age 19 and above ( no age limit for elderly )
  • Patients with cardiogenic shock requiring intensive care monitoring in ICU
  • Patients eligible for oral medication administration
  • Patients who have provided research participation consent through a written informed consent form

排除标准

  • Unwilling or unable to obtain informed consent by the participant or substitute decision maker
  • Patients with mechanical circulatory support at the time of screening
  • Patients with acute coronary syndrome
  • Patients with severe valvular heart disease requiring emergent percutaneous procedures or surgery
  • Known hypersensitivity to beta-blockers
  • Patients with a history of bronchospasm or asthma
  • Patients with bradycardia or second or third-degree atrioventricular block
  • Patients with sick sinus syndrome, including sinoatrial block
  • Patients with untreated pheochromocytoma
  • Patients currently undergoing de-sensitization therapy
  • Patients who are currently pregnant, postpartum period within 30 days or breast-feeding

结局指标

主要结局

30-day all-cause mortality

时间窗: From date of randomization until the date of death from any cause, assessed up to 30 days

All-cause mortality

次要结局

  • Cardiovascular mortality(From date of randomization until the date of death from any cause, assessed up to 3 months)
  • Complications related with pulmonary artery catheter(During hospitalization period, up to 30 days)
  • The rate of Carvedilol intake on the 3 months(3 months from date of randomization)
  • The target-dose achievement rate of Carvedilol on the 3 months(3 months from date of randomization)
  • Timing of discontinuation of inotropic or vasopressor agents(From date of randomization until the date of discharge or assessed up to 90 days)
  • Hospitalization due to heart failure(3 months from date of randomization)
  • The composite outcome of cardoivascular death and heart failure hospitalization(3 months from date of randomization)
  • All-cause mortality(From date of randomization until the date of death from any cause, assessed up to 3 months)
  • 3-month follow-up echocardiography parameters(3 months from date of randomization)

研究者

发起方
Min-Seok Kim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Min-Seok Kim

Clinical Associate Professor

Asan Medical Center

研究点 (2)

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