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

ConditionsHeart Failure With Reduced Ejection FractionCardiogenic Shock
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorMin-Seok Kim

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pulmonary artery catheter

    Device

    Pulmonary artery catheter monitoring or not

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Pulmonary artery catheter monitoring groupExperimental treatment 1 intervention
Group B: No pulmonary artery catheter monitoring groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

30-day all-cause mortality

All-cause mortality

Time frame
From date of randomization until the date of death from any cause, assessed up to 30 days

Secondary outcomes

1

All-cause mortality

All-cause of death

Time frame
From date of randomization until the date of death from any cause, assessed up to 3 months
2

Cardiovascular mortality

Cardiovascular death

Time frame
From date of randomization until the date of death from any cause, assessed up to 3 months
3

Timing of discontinuation of inotropic or vasopressor agents

Days from randomization to discontinuation of inotropes/vasopressor

Time frame
From date of randomization until the date of discharge or assessed up to 90 days
4

The rate of Carvedilol intake on the 3 months

The rate of Carvedilol intake

Time frame
3 months from date of randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Min-Seok Kim

Lead sponsor

Asan Medical Center

Sponsor institution

Source ClinicalTrials.gov
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