← Back to Search

Hemodynamic Monitoring Device

Pulmonary Artery Catheter for Cardiogenic Shock (PACCS Trial)

N/A

Recruiting

Led By Navin K Kapur, MD

Research Sponsored by Tufts Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical heart failure presentation with specific left ventricular function criteria

Age ≥18 years and ≤90 years

Must not have

Severe valvular diseases or infective endocarditis

Congenital heart disease excluding the presence of a bicuspid aortic valve

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether or not a PAC (a type of heart monitor) can help improve outcomes for patients with heart failure who are in cardiogenic shock.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from using a Pulmonary Artery Catheter may include bleeding at the insertion site, infection risk increase due to an invasive procedure, irregular heartbeat during placement, blood vessel damage or lung injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have heart failure with specific issues in my heart's left side.

Select...

I am between 18 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have severe heart valve disease or heart infection.

Select...

I have a heart condition from birth, but it's not a bicuspid aortic valve.

Select...

My shock is not due to left heart failure.

Select...

I am on dialysis before joining the study.

Select...

I have had a stroke or brain bleeding, or I have a condition that increases my risk of brain bleeding.

Select...

I have a history of heart amyloidosis.

Select...

I am scheduled for heart surgery during my hospital stay.

Select...

I was moved to this hospital with a diagnosis of severe heart failure.

Select...

My condition is a type of high blood pressure that affects the arteries in my lungs and heart.

Select...

I have had a heart attack that did not respond to treatment within the last day.

Select...

I have suffered a brain injury due to lack of oxygen.

Select...

I do not have any health conditions expected to shorten my life to under 6 months, aside from heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 14Eligibility criteria met