Cardiogenic Shock Working Group Registry (CSWG)

Tufts University

Status: Enrolling

Conditions: Cardiogenic Shock

Treatments: Drug: Inotrope; Device: Acute Mechanical Circulatory Support Devices; Drug: Vasopressor

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04682483

12670

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients must have cardiogenic shock.

Cardiogenic shock is defined by at least one of the two categories below:

1. 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

2. 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.

Trial design

5,000 participants in 1 patient group

Cardiogenic Shock Patients

Description:

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.

Treatment:

Drug: Vasopressor

Device: Acute Mechanical Circulatory Support Devices

Drug: Inotrope