Observational study on cardiac output measurement in patients with cardiogenic shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop algorithms for determining cardiac output by synchronously acquiring hemodynamic data from pulmonary artery catheters and Impella devices. It focuses on patients receiving intensive care management with Impella support, utilizing both continuous and discontinuous cardiac output measurement methods. The goal is to explore non-invasive alternatives to traditional hemodynamic monitoring, potentially improving patient management in critical care settings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Ongoing or planned intensive care management with Impella support
2. Presence or planned placement of a cardiac output measurement

   1. Preferentially pulmonary catheter (including cardiac output (CO) preferred as continuous measurement)
   2. Other means of discontinuous CO measurement incl. echocardiography, other thermodilution methods

Exclusion Criteria:

1. Age \< 18 years
2. Pregnancy
3. Anticipated support duration \<24 h

Where it's running

• Universitätsspital Basel
  Basel, Switzerland Recruiting
• Uniklinik RWTH Aachen
  Aachen, North Rhine-Westphalia, Germany Active not recruiting
• UKSH Campus Kiel
  Kiel, Schleswig-Holstein, Germany Not yet recruiting
• IRCCS Ospedale San Raffaele
  Milan, Mi, Italy Not yet recruiting

Study contacts

• Principal investigator: Alexander Kersten, MD — Uniklinik RWTH Aachen, Klinik für Kardiologie, Angiologie und Internistische Intensivmedizin
• Study coordinator: Andreas Goetzenich, MD, PhD, MBA, FAHA, FESC
• Email: AGoetze1@ITS.JNJ.com
• Phone: +49 241 8860

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Factors Influencing Outcomes in ECMO and Impella Patients

  This study tests whether metabolic and thyroid hormone changes help predict survival for adults on ECMO or Impella at a single Hungarian cardiac ICU.

  Recruiting Gottsegen National Cardiovascular Institute · Budapest · NCT07885618

• Evaluating a noninvasive tissue sensor to detect cardiogenic shock earlier in heart patients

  This pilot, noninvasive study tests whether the NIRSense wearable can help detect deterioration in adults with cardiogenic shock risk due to heart attack or heart failure.

  Recruiting NIRSense Inc. · Weston, Florida · NCT07825363

• Safety and Efficacy of an Extracorporeal Ventricular Assist System for Cardiogenic Shock

  This study tests whether an extracorporeal ventricular assist device can safely provide short-term heart support and help patients with cardiogenic shock or trouble weaning from bypass.

  Recruiting China National Center for Cardiovascular Diseases · Beijing, Beijing Municipality · NCT07769528

• Left Ventricular Support and Advanced Monitoring in AMI–Cardiogenic Shock: Immediate Impella Use and PAC/Monitoring vs Standard Care

  In adults with heart attack-related cardiogenic shock, this trial tests whether using an Impella left ventricular assist device and/or protocolized pulmonary artery catheter monitoring improves survival compared with standard care.

  Recruiting Leipzig Heart Science gGmbH · Leipzig, Saxony · NCT07762560

• CRP Apheresis for infarct-related cardiogenic shock

  This study tests whether selectively removing C-reactive protein with apheresis, in addition to standard care, helps people with cardiogenic shock after a heart attack.

  Recruiting Leipzig Heart Science gGmbH · Leipzig, Saxony · NCT07687017

• Compare two ventilator modes in adults with cardiac ICU needs and invasive ventilation

  This pilot tests whether volume-controlled versus pressure-controlled ventilation can be safely used in adults with heart disease and respiratory failure who need invasive ventilation.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07656259

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.