DRUG
Vasopressor
The vasopressors include phenylephrine, norepinephrine, epinephrine, dopamine and vasopressin.
Cardiogenic Shock Working Group Registry
Status
Recruiting
Phase
Not applicable
Enrollment
5,000
Locations
16
Results
Not posted
Publications
10
Study summary
What the protocol is testing.
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 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
Treatment arms and agents.
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.
Timeline
From registration to results.
First posted
Dec 23, 2020
Study start
Dec 4, 2017
Primary completion
Jan 1, 2026
Study completion
Jun 1, 2026
Results posted
Not reported
Registry updated
Jun 6, 2025
Outcomes
What the study measures.
Primary outcomes
Rate of Mortality
Time frame · 30 days after discharge
Death in subjects during the time frame.
Rate of Mortality
Time frame · 1 year after discharge
Death in subjects during the time frame.
Secondary outcomes
Rate of Re-hospitalization
Time frame · 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.
Rate of Re-hospitalization
Time frame · 1 year 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
Time frame · 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
New York Heart Association (NYHA) Class
Time frame · 1 year 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
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- 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.
Study locations
16 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Cleveland Clinic Florida
Weston, Florida, United States
Northwestern Medicine
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Maine Medical Center
Portland, Maine, United States
Tufts Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Hackensack Meridian Health
Hackensack, New Jersey, United States
Columbia University Irving Medical Center
New York, New York, United States
Providence St. Vincent Heart Clinic
Portland, Oregon, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University Of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Baylor Scott & White Advanced Heart Failure Clinic
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Inova Health System
Falls Church, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Publications
Results and literature.
PMID 32280413 ↗Kapur NK, Thayer KL, Zweck E. Cardiogenic Shock in the Setting of Acute Myocardial Infarction. Methodist Debakey Cardiovasc J. 2020 Jan-Mar;16(1):16-21. doi: 10.14797/mdcj-16-1-16.PMID 32352638 ↗Pahuja M, Chehab O, Ranka S, Mishra T, Ando T, Yassin AS, Thayer KL, Shah P, Kimmelstiel CD, Salehi P, Kapur NK. Incidence and clinical outcomes of stroke in ST-elevation myocardial infarction and cardiogenic shock. Catheter Cardiovasc Interv. 2021 Feb 1;97(2):217-225. doi: 10.1002/ccd.28919. Epub 2020 Apr 30.PMID 32900234 ↗Thayer KL, Zweck E, Ayouty M, Garan AR, Hernandez-Montfort J, Mahr C, Morine KJ, Newman S, Jorde L, Haywood JL, Harwani NM, Esposito ML, Davila CD, Wencker D, Sinha SS, Vorovich E, Abraham J, O'Neill W, Udelson J, Burkhoff D, Kapur NK. Invasive Hemodynamic Assessment and Classification of In-Hospital Mortality Risk Among Patients With Cardiogenic Shock. Circ Heart Fail. 2020 Sep;13(9):e007099. doi: 10.1161/CIRCHEARTFAILURE.120.007099. Epub 2020 Sep 9.PMID 32487943 ↗Whitehead E, Thayer K, Kapur NK. Clinical trials of acute mechanical circulatory support in cardiogenic shock and high-risk percutaneous coronary intervention. Curr Opin Cardiol. 2020 Jul;35(4):332-340. doi: 10.1097/HCO.0000000000000751.PMID 32765837 ↗Kapur NK, Whitehead EH, Thayer KL, Pahuja M. The science of safety: complications associated with the use of mechanical circulatory support in cardiogenic shock and best practices to maximize safety. F1000Res. 2020 Jul 29;9:F1000 Faculty Rev-794. doi: 10.12688/f1000research.25518.1. eCollection 2020.PMID 33121702 ↗Garan AR, Kanwar M, Thayer KL, Whitehead E, Zweck E, Hernandez-Montfort J, Mahr C, Haywood JL, Harwani NM, Wencker D, Sinha SS, Vorovich E, Abraham J, O'Neill W, Burkhoff D, Kapur NK. Complete Hemodynamic Profiling With Pulmonary Artery Catheters in Cardiogenic Shock Is Associated With Lower In-Hospital Mortality. JACC Heart Fail. 2020 Nov;8(11):903-913. doi: 10.1016/j.jchf.2020.08.012.PMID 33005634 ↗Whitehead EH, Thayer KL, Burkhoff D, Uriel N, Ohman EM, O'Neill W, Kapur NK. Central Venous Pressure and Clinical Outcomes During Left-Sided Mechanical Support for Acute Myocardial Infarction and Cardiogenic Shock. Front Cardiovasc Med. 2020 Aug 28;7:155. doi: 10.3389/fcvm.2020.00155. eCollection 2020.PMID 32473083 ↗Pahuja M, Ranka S, Chehab O, Mishra T, Akintoye E, Adegbala O, Yassin AS, Ando T, Thayer KL, Shah P, Kimmelstiel CD, Salehi P, Kapur NK. Incidence and clinical outcomes of bleeding complications and acute limb ischemia in STEMI and cardiogenic shock. Catheter Cardiovasc Interv. 2021 May 1;97(6):1129-1138. doi: 10.1002/ccd.29003. Epub 2020 May 30.PMID 36342421 ↗Hernandez-Montfort J, Kanwar M, Sinha SS, Garan AR, Blumer V, Kataria R, Whitehead EH, Yin M, Li B, Zhang Y, Thayer KL, Baca P, Dieng F, Harwani NM, Guglin M, Abraham J, Hickey G, Nathan S, Wencker D, Hall S, Schwartzman A, Khalife W, Li S, Mahr C, Kim J, Vorovich E, Pahuja M, Burkhoff D, Kapur NK. Clinical Presentation and In-Hospital Trajectory of Heart Failure and Cardiogenic Shock. JACC Heart Fail. 2023 Feb;11(2):176-187. doi: 10.1016/j.jchf.2022.10.002. Epub 2022 Oct 31.PMID 35835491 ↗Kapur NK, Kanwar M, Sinha SS, Thayer KL, Garan AR, Hernandez-Montfort J, Zhang Y, Li B, Baca P, Dieng F, Harwani NM, Abraham J, Hickey G, Nathan S, Wencker D, Hall S, Schwartzman A, Khalife W, Li S, Mahr C, Kim JH, Vorovich E, Whitehead EH, Blumer V, Burkhoff D. Criteria for Defining Stages of Cardiogenic Shock Severity. J Am Coll Cardiol. 2022 Jul 19;80(3):185-198. doi: 10.1016/j.jacc.2022.04.049.
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