Cardiogenic Shock
Conditions
Keywords
Cardiogenic Shock, mechanical circulatory support, hemodynamics, heart failure, acute myocardial infarction, registry, critical care, clinical outcomes research
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.
Interventions
DRUGVasopressor
The vasopressors include phenylephrine, norepinephrine, epinephrine, dopamine and vasopressin.
DRUGInotrope
Inotropes include dobutamine and milrinone.
DEVICEAcute Mechanical Circulatory Support Devices
Acute Mechanical Circulatory Support devices include ECMO (VV), ECMO (VA), Impella CP, Impella 2.5, Impella 5.0, Impella 5.5, Impella RP, IABP, Centrimag, Tandem Heart and ProTek Duo.
Sponsors
Abbott
Boston Scientific Corporation
Abiomed Inc.
Getinge Group
Tufts Medical Center
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Mortality | 30 days after discharge | Death in subjects during the time frame. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Re-hospitalization | 30 day 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 | 30 day 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 |
Countries
United States
Contacts
Primary ContactNavin K Kapur, MD
Outcome results
None listed