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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 96 hours of randomization
Awards & highlights
PACCS Trial 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.Check my eligibility
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.See study design
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.
PACCS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have heart failure with specific issues in my heart's left side.
Select...
I am between 18 and 90 years old.
PACCS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 96 hours of randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 96 hours of randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants who die in the hospital
Secondary outcome measures
Admission to an outpatient IV diuretic center
Death
Heart failure hospitalizations/emergency room visits
+5 morePACCS 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.
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Who is running the clinical trial?
Tufts Medical CenterLead Sponsor
259 Previous Clinical Trials
263,813 Total Patients Enrolled
Navin K Kapur, MDPrincipal Investigatornkapur@tuftsmedicalcenter.org
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition called cardiogenic shock, which is identified by specific test results showing high lactate levels and other specific measurements.I am on the waiting list for a heart transplant.You have a "do not resuscitate" or "do not intubate" status.Your blood tests show a high INR level, a low platelet count, or low hemoglobin levels.You are pregnant, gave birth within the last 6 months, or are breastfeeding.I do not have severe heart valve disease or heart infection.You have a confirmed ongoing infection with a persistent fever or bacteria in your blood.You have a condition that makes it unsafe for you to have a PAC (peripherally inserted central catheter) placed.I have a heart condition from birth, but it's not a bicuspid aortic valve.I have heart failure with specific issues in my heart's left side.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 had heart surgery within the last 3 months.I have a history of heart amyloidosis.You have had a pacemaker or defibrillator implanted in the last 3 months.You have a mechanical problem related to a heart attack.You tested positive for COVID-19 in the past 4 weeks.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 am between 18 and 90 years old.I was hospitalized for COVID-19 but have been symptom-free for at least 4 weeks.You have a long-term ventricular assist device or temporary mechanical circulatory support.I do not have any health conditions expected to shorten my life to under 6 months, aside from heart failure.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Early Pulmonary Artery Catheter
- Group 2: No or delayed Pulmonary Artery Catheter
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