Trial Summary
What is the purpose of this trial?The primary objective of the PACCS trial is to assess if early invasive hemodynamic assessment and ongoing management with a PAC in patients with cardiogenic shock due to acutely decompensated heart failure (AHDF-CS) is associated with lower in-hospital mortality risk compared to the current standard of care with no or delayed PAC assessment.
Is the Pulmonary Artery Catheter a promising treatment for cardiogenic shock?The Pulmonary Artery Catheter (PAC) is a tool used to monitor heart function in patients with cardiogenic shock. Research is still ongoing to determine its effectiveness in improving survival rates, but it is considered a valuable tool for managing heart conditions during critical care.24568
What safety data exists for pulmonary artery catheter use in cardiogenic shock?The safety data for pulmonary artery catheter (PAC) use, including Swan-Ganz catheters, in cardiogenic shock indicates several potential complications. These include mechanical issues like catheter dysfunction and malposition, as well as serious complications such as pulmonary artery rupture, which occurs in less than 0.2% of cases. The insertion procedure itself carries risks of hematoma, arterial puncture, pneumothorax, hemothorax, and cardiac chamber perforation. Standardizing the insertion technique may help reduce these risks. Despite these complications, PAC is frequently used for hemodynamic monitoring in critically ill patients.12346
What data supports the idea that Pulmonary Artery Catheter for Cardiogenic Shock is an effective treatment?The available research shows that the effectiveness of using a Pulmonary Artery Catheter for treating cardiogenic shock is not clearly established. Several studies, including systematic reviews and meta-analyses, have explored its impact on survival rates, but the results remain controversial. There is no strong evidence from these studies to conclusively support that this treatment significantly improves survival outcomes compared to other treatments for cardiogenic shock.46789
Do I need to stop my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Eligibility Criteria
This trial is for adults aged 18-90 with heart failure leading to cardiogenic shock, diagnosed within the last 24 hours. Participants must consent and meet specific criteria related to heart function and lactate levels. Exclusions include severe other conditions, recent COVID-19 hospitalization, certain prior treatments like ventricular assist devices or transplants, active infections, bleeding risks, and pregnancy.Inclusion Criteria
I have heart failure with specific issues in my heart's left side.
I am between 18 and 90 years old.
Exclusion Criteria
I do not have severe heart valve disease or heart infection.
I have a heart condition from birth, but it's not a bicuspid aortic valve.
My shock is not due to left heart failure.
I am on dialysis before joining the study.
I have had a stroke or brain bleeding, or I have a condition that increases my risk of brain bleeding.
I have a history of heart amyloidosis.
I am scheduled for heart surgery during my hospital stay.
I was moved to this hospital with a diagnosis of severe heart failure.
My condition is a type of high blood pressure that affects the arteries in my lungs and heart.
I have had a heart attack that did not respond to treatment within the last day.
I have suffered a brain injury due to lack of oxygen.
I do not have any health conditions expected to shorten my life to under 6 months, aside from heart failure.
Treatment Details
The PACCS trial is testing if using a Pulmonary Artery Catheter (PAC) right away in patients with acute heart failure-induced cardiogenic shock can reduce the risk of dying in the hospital compared to standard care without immediate PAC use.
2Treatment groups
Experimental Treatment
Active Control
Group I: Early Pulmonary Artery CatheterExperimental Treatment1 Intervention
If you are in the experimental group a PAC will be placed within 6 hours of randomization and within 24 hours of presentation with ADHF-CS.
Group II: No or delayed Pulmonary Artery CatheterActive Control1 Intervention
If you are in the control group, a PAC will not be placed during hospitalization or may be placed 48 hours after randomization into the study. Placement of a PAC within 48 hours is only permitted for emergencies.
Pulmonary Artery Catheter is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Pulmonary Artery Catheter for:
- Cardiogenic shock
- Pulmonary hypertension
- Severe heart failure
- Complex heart attacks
- Unstable conditions before or after surgery
- Severe preeclampsia
🇪🇺 Approved in European Union as Pulmonary Artery Catheter for:
- Cardiogenic shock
- Pulmonary hypertension
- Severe heart failure
- Complex heart attacks
- Unstable conditions before or after surgery
- Severe preeclampsia
🇨🇦 Approved in Canada as Pulmonary Artery Catheter for:
- Cardiogenic shock
- Pulmonary hypertension
- Severe heart failure
- Complex heart attacks
- Unstable conditions before or after surgery
- Severe preeclampsia
Find a clinic near you
Research locations nearbySelect from list below to view details:
Tufts Medical CenterBoston, MA
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Who is running the clinical trial?
Tufts Medical CenterLead Sponsor
References
The two-headed swan. [2018]Pulmonary artery catheterization is a frequent procedure for hemodynamic monitoring in critically ill patients or high-risk surgical patients. Mechanical and infectious complications are recognized, though catheter dysfunction and malposition are more frequent and often require clinical intervention. We present the case of a Swan-Ganz catheter with the appearance of a mechanical fracture at the distal end, which required clinical and radiographic investigation to determine the nature of the aberrancy. The evaluation of a malfunctioning pulmonary artery catheter (PAC) is a frequent occurrence in the intensive care unit and requires careful clinical consideration and radiographic examination.
[Insertion procedure of the Swan-Ganz catheter]. [2010]The Swan-Ganz catheter (the pulmonary artery catheter: PAC) has been used to examine the heart diseases and to evaluate the hemodynamics by the physician in the catheter laboratory and beside the patient's bed. It is also used to monitor the hemodynamics during the cardiac surgery in the operating theater and to manage the patient in the intensive care unit (ICU) postoperatively. A very careful insertion technique is mandatory to avoid various serious complications, such as hematoma formation, arterial centesis, pneumothorax, hemothorax, perforation from cardiac chambers, rupture of the pulmonary artery, and so on. To reduce these complications, standardization of the insertion technique could be useful. When a complication unfortunately occurrs during insertion before surgery, it should be considered to abandon the following operation to avoid catastrophe.
Pulmonary artery rupture as a complication of Swan-Ganz catheter application. Diagnosis and endovascular treatment: a single centre's experience. [2022]The placement of a Swan-Ganz catheter into the pulmonary artery may lead to a number of complications (2-17%). In less than 0.2% of cases Swan-Ganz catheterization results in serious vascular damage - pulmonary artery rupture (PAR). This paper presents two distinct forms of iatrogenic PAR treated endovascularly using different vascular devices.
Impact of Pulmonary Artery Catheter Use on Short- and Long-Term Mortality in Patients with Cardiogenic Shock. [2018]The impact of pulmonary artery catheterization (PAC) on survival in patients with cardiogenic shock (CS) is not well established. This study aimed to assess whether Swan-Ganz catheter monitoring is related to short- and long-term mortality in patients with CS.
Pulmonary artery catheter use in acute myocardial infarction-cardiogenic shock. [2021]The aim of this study is to evaluate the contemporary use of a pulmonary artery catheter (PAC) in acute myocardial infarction-cardiogenic shock (AMI-CS).
Pulmonary artery catheterization in patients with cardiogenic shock: a systematic review and meta-analysis. [2022]Cardiogenic shock carries high morbidity and mortality. The purpose of this review was to determine the safety and efficacy of pulmonary artery catheterization (PAC) in adult patients hospitalized with cardiogenic shock.
Prognostic implications of pulmonary artery catheter monitoring in patients with cardiogenic shock: A systematic review and meta-analysis of observational studies. [2022]To investigate the impact of pulmonary artery catheter (PAC) monitoring on survival of cardiogenic shock(CS), in the light of the controversies in available evidence.
Clinical impact of pulmonary artery catheter in patients with cardiogenic shock: A systematic review and meta-analysis. [2023]The clinical utility of the pulmonary artery catheter (PAC) for the management of cardiogenic shock (CS) remains controversial. We performed a systematic review and meta-analysis exploring the association between PAC use and mortality among patients with CS.
Pulmonary Artery Catheter Usage and Impact on Mortality in Patients with Cardiogenic Shock: Results from a Canadian, Single Centre Registry. [2023]Hemodynamic assessment for cardiogenic shock (CS) phenotyping in patients has led to renewed interest in the use of pulmonary artery catheters (PAC).