Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06078436
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-09-20
Brief Title:
Pulmonary Artery Catheterization and Carvedilol Early Initiation in Cardiogenic SHOCK Due to HFrEF
Sponsor:
Min-Seok Kim
Organization:
Asan Medical Center
Study Overview
Official Title:
Pulmonary Artery Catheterization and Carvedilol Early Initiation in Cardiogenic SHOCK Caused by Heart Failure With Reduced Ejection Fraction
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACE-SHOCK
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 mmolL or more compared to the lowest value within 24 hours mechanical circulatory support MCS is considered The specific dosage of vasopressorsinotropes 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 mmolL or more compared to the lowest value within 24 hours mechanical circulatory support MCS is considered The specific dosage of vasopressorsinotropes 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 vasopressorinotropic 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 vasopressorsinotropic 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
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 mmolL or more compared to the lowest value within 24 hours mechanical circulatory support MCS is considered The specific dosage of vasopressorsinotropes 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 mmolL or more compared to the lowest value within 24 hours mechanical circulatory support MCS is considered The specific dosage of vasopressorsinotropes 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 vasopressorinotropic 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 vasopressorsinotropic 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None