Pulmonary Artery Catheterization and Carvedilol Early Initiation in Cardiogenic SHOCK Due to HFrEF

NCT ID: NCT06078436

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2028-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Heart Failure With Reduced Ejection Fraction; Cardiogenic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pulmonary artery catheter monitoring group

Within 8 hours of random allocation, a pulmonary artery catheter will be inserted to monitor hemodynamic parameters.

Group Type: EXPERIMENTAL

Pulmonary artery catheter

Intervention Type: DEVICE

Pulmonary artery catheter monitoring or not

No pulmonary artery catheter monitoring group

After random allocation, a pulmonary artery catheter will not be inserted during cardiogenic shock management.

Group Type: ACTIVE_COMPARATOR

Pulmonary artery catheter

Intervention Type: DEVICE

Pulmonary artery catheter monitoring or not

Interventions

Pulmonary artery catheter

Pulmonary artery catheter monitoring or not

Intervention Type: DEVICE

Other Intervention Names

Swan-Ganz catheter

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Min-Seok Kim

OTHER

Sponsor Role: lead

Responsible Party

Min-Seok Kim

Clinical Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Min-Seok Kim

Role: STUDY_CHAIR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Min-Seok Kim, PhD

Role: CONTACT

msk@amc.seoul.kr

82-2-3010-3948

Ah-Ram Kim, MD

Role: CONTACT

ahram3256@amc.seoul.kr

82-2-3010-0111

Facility Contacts

Min Seok Kim, PhD

Role: primary

msk@amc.seoul.kr

02-3010-3948

Ah-Ram Kim, MD

Role: backup

ahram3256@amc.seoul.kr

02-3010-0111

Other Identifiers

AMC_2023_0794

Identifier Type: -

Identifier Source: org_study_id