Cardiogenic Shock Working Group Registry

Tufts Medical Center5,000 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

5,000

Conditions

Cardiogenic Shock

Interventions

VasopressorDRUG

The vasopressors include phenylephrine, norepinephrine, epinephrine, dopamine and vasopressin.

InotropeDRUG

Inotropes include dobutamine and milrinone.

Acute Mechanical Circulatory Support DevicesDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

Cleveland Clinic Florida

Weston, Florida, United States

RECRUITING

Northwestern Medicine

Outcomes

Primary Outcomes

Rate of Mortality

Death in subjects during the time frame.

Time frame: 30 days after discharge

Rate of Mortality

Death in subjects during the time frame.

Time frame: 1 year after discharge

Secondary Outcomes

Rate of Re-hospitalization

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.

Time frame: 30 day after discharge

Rate of Re-hospitalization

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.

Time frame: 1 year after discharge

New York Heart Association (NYHA) Class

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

Time frame: 30 day after discharge

New York Heart Association (NYHA) Class

Central Contacts

Navin K Kapur, MD

CONTACT

6176368252 nkapur@tuftsmedicalcenter.org

Data from ClinicalTrials.gov

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