Cardiogenic Shock Working Group Registry

Purpose

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.

Condition

  • Cardiogenic Shock

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Vasopressor
    The vasopressors include phenylephrine, norepinephrine, epinephrine, dopamine and vasopressin.
  • Drug: Inotrope
    Inotropes include dobutamine and milrinone.
  • Device: Acute 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.

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555
Contact:
Wissam Khalife, MD

More Details

Status
Recruiting
Sponsor
Tufts Medical Center

Study Contact

Navin K Kapur, MD
6176368252
nkapur@tuftsmedicalcenter.org

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.