Pulmonary Artery Catheterization and Carvedilol Early Initiation in Cardiogenic SHOCK Due to HFrEF (PACE-SHOCK)

January 3, 2024 updated by: Min-Seok Kim

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulmonary artery catheter monitoring group
Within 8 hours of random allocation, a pulmonary artery catheter will be inserted to monitor hemodynamic parameters.
Device: Pulmonary artery catheter
Pulmonary artery catheter monitoring or not
Other Names:
  • Swan-Ganz catheter
Active Comparator: No pulmonary artery catheter monitoring group
After random allocation, a pulmonary artery catheter will not be inserted during cardiogenic shock management.
Device: Pulmonary artery catheter
Pulmonary artery catheter monitoring or not
Other Names:
  • Swan-Ganz catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day all-cause mortality
Time Frame: From date of randomization until the date of death from any cause, assessed up to 30 days
All-cause mortality
From date of randomization until the date of death from any cause, assessed up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timing of discontinuation of inotropic or vasopressor agents
Time Frame: From date of randomization until the date of discharge or assessed up to 90 days
Days from randomization to discontinuation of inotropes/vasopressor
From date of randomization until the date of discharge or assessed up to 90 days
The rate of Carvedilol intake on the 3 months
Time Frame: 3 months from date of randomization
The rate of Carvedilol intake
3 months from date of randomization
The target-dose achievement rate of Carvedilol on the 3 months
Time Frame: 3 months from date of randomization
Target dose : 50mg/day
3 months from date of randomization
Complications related with pulmonary artery catheter
Time Frame: During hospitalization period, up to 30 days
Any complications related with pulmonary artery catheter
During hospitalization period, up to 30 days
All-cause mortality
Time Frame: From date of randomization until the date of death from any cause, assessed up to 3 months
All-cause of death
From date of randomization until the date of death from any cause, assessed up to 3 months
Cardiovascular mortality
Time Frame: From date of randomization until the date of death from any cause, assessed up to 3 months
Cardiovascular death
From date of randomization until the date of death from any cause, assessed up to 3 months
3-month follow-up echocardiography parameters
Time Frame: 3 months from date of randomization
LVEF(left ventricular ejection fraction)
3 months from date of randomization
Hospitalization due to heart failure
Time Frame: 3 months from date of randomization
Unplanned hospitalization due to heart failure
3 months from date of randomization
The composite outcome of cardoivascular death and heart failure hospitalization
Time Frame: 3 months from date of randomization
The composite outcome of cardiovascular death and hospitalization due to heart failure
3 months from date of randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Min-Seok Kim

Investigators

  • Study Chair: Min-Seok Kim, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC_2023_0794

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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