Cardiogenic Shock Working Group Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Tufts Medical Center
- Enrollment
- 5,000
- Locations
- 16
- Primary Endpoint
- Rate of Mortality
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- Not provided
Arms & Interventions
Cardiogenic Shock Patients
Cardiogenic Shock patients eligible for this study are defined by at least one of the two categories below.
- 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.
- Patients require the use of at least 1 vasopressor, inotrope or acute mechanical circulatory support device to maintain values above the above targets.
Intervention: Vasopressor (Drug)
Cardiogenic Shock Patients
Cardiogenic Shock patients eligible for this study are defined by at least one of the two categories below.
- 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.
- Patients require the use of at least 1 vasopressor, inotrope or acute mechanical circulatory support device to maintain values above the above targets.
Intervention: Inotrope (Drug)
Cardiogenic Shock Patients
Cardiogenic Shock patients eligible for this study are defined by at least one of the two categories below.
- 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.
- Patients require the use of at least 1 vasopressor, inotrope or acute mechanical circulatory support device to maintain values above the above targets.
Intervention: Acute Mechanical Circulatory Support Devices (Device)
Outcomes
Primary Outcomes
Rate of Mortality
Time Frame: 1 year after discharge
Death in subjects during the time frame.
Secondary Outcomes
- Rate of Re-hospitalization(1 year after discharge)
- New York Heart Association (NYHA) Class(1 year after discharge)