Cardiogenic Shock Working Group Registry
- Conditions
- Cardiogenic Shock
- Interventions
- Drug: VasopressorDrug: InotropeDevice: Acute Mechanical Circulatory Support Devices
- Registration Number
- NCT04682483
- Lead Sponsor
- Tufts Medical Center
- Brief Summary
The Cardiogenic Shock Working Group is a multicenter registry where we collect de-identified clinical variables from the medical records and follow-up phone calls of shock patients from multiple institutions and centralize this data to a single registry for analysis of clinical outcomes.
- Detailed Description
The Cardiogenic Shock Working Group is an Academic Research Consortium involving multiple medical centers within the United States and includes a multicenter registry for patients with cardiogenic shock. De-identified clinical variables are collected from medical records and follow-up phone calls. There is currently no central database for cardiogenic shock, therefore analysis of cardiogenic shock on a larger scale is limited. A goal of the Cardiogenic Shock Working Group is to create a centralized registry, compiled of data from multiple institutions, to analyze clinical outcomes. The Cardiogenic Shock Working Group Registry will include a retrospective arm, where data is collected during the course of the hospital stay, and a prospective arm, where long-term outcomes will be assessed.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- Patients must have cardiogenic shock.
Cardiogenic shock is defined by at least one of the two categories below:
-
At least 2 of the following concurrently at any point during the index hospitalization:
- Cardiac Index < 2.2
- PAPI < 1.0
- Cardiac Power Output ≤ 0.6
- MAP < 60mmHg or a >30mmHg drop in MAP from baseline
- SBP < 90mmHg or a >30mmHg drop in SBP from baseline
- Pulse > 100
-
Require at least one acute mechanical circulatory support device, vasopressor or inotrope to maintain values above the above target.
Post-cardiotomy patients must meet the inclusion criteria 72 hours after their surgery to be included in this registry.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cardiogenic Shock Patients Vasopressor Cardiogenic Shock patients eligible for this study are defined by at least one of the two categories below. 1. Patients have at least 2 of the following concurrently at any point during the index hospitalization: MAP \< 60mmHg or a \>30mmHg drop in MAP from baseline, SBP \< 90mmHg or a \>30mmHg drop in SBP from baseline, Pulse \> 100, Cardiac Index \< 2.2, Cardiac Power Output ≤ 0.6 or PAPI \< 1.0. 2. Patients require the use of at least 1 vasopressor, inotrope or acute mechanical circulatory support device to maintain values above the above targets. Cardiogenic Shock Patients Inotrope Cardiogenic Shock patients eligible for this study are defined by at least one of the two categories below. 1. Patients have at least 2 of the following concurrently at any point during the index hospitalization: MAP \< 60mmHg or a \>30mmHg drop in MAP from baseline, SBP \< 90mmHg or a \>30mmHg drop in SBP from baseline, Pulse \> 100, Cardiac Index \< 2.2, Cardiac Power Output ≤ 0.6 or PAPI \< 1.0. 2. Patients require the use of at least 1 vasopressor, inotrope or acute mechanical circulatory support device to maintain values above the above targets. Cardiogenic Shock Patients Acute Mechanical Circulatory Support Devices Cardiogenic Shock patients eligible for this study are defined by at least one of the two categories below. 1. Patients have at least 2 of the following concurrently at any point during the index hospitalization: MAP \< 60mmHg or a \>30mmHg drop in MAP from baseline, SBP \< 90mmHg or a \>30mmHg drop in SBP from baseline, Pulse \> 100, Cardiac Index \< 2.2, Cardiac Power Output ≤ 0.6 or PAPI \< 1.0. 2. Patients require the use of at least 1 vasopressor, inotrope or acute mechanical circulatory support device to maintain values above the above targets.
- Primary Outcome Measures
Name Time Method Rate of Mortality 1 year after discharge Death in subjects during the time frame.
- Secondary Outcome Measures
Name Time Method Rate of Re-hospitalization 1 year after discharge We will be observing if patient was hospitalized again during the 1 year-time frame. We will collect information on surgeries and interventions during the course of rehospitalization.
New York Heart Association (NYHA) Class 1 year after discharge NYHA Classification provides a way to classify the stages of heart failure. Class I- No symptoms and no limitation in ordinary physical activity Class II- Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV - Severe limitations
Trial Locations
- Locations (16)
University Of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Hackensack Meridian Health
🇺🇸Hackensack, New Jersey, United States
Baylor Scott & White Advanced Heart Failure Clinic
🇺🇸Dallas, Texas, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Northwestern Medicine
🇺🇸Chicago, Illinois, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Columbia University Irving Medical Center
🇺🇸New York, New York, United States
Inova Health System
🇺🇸Falls Church, Virginia, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Providence St. Vincent Heart Clinic
🇺🇸Portland, Oregon, United States