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Recruiting NCT06308055

Abiomed Impella RT-DAQ - Observational Study

— Observational Cardiogenic Shock

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data Acquisition.
Who it may be relevant to
Registry conditions: Cardiogenic Shock. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, Italy, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition

Overview

Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition

Detailed description

The objective of this study is to develop algorithms for determining the cardiac output through the synchronous acquisition of hemodynamic data from the pulmonary artery catheter or other pressure sensors and Impella using a network module, which can replace invasive hemodynamic monitoring in the future.

Interventions

  • Other Data Acquisition
    Develop algorithms for determining the cardiac output through the synchronous acquisition of hemodynamic data from the pulmonary artery catheter or other pressure sensors and Impella using a network module.

Primary outcome measures

  • Collection of hemodynamic parameters (Cardiac Output in l/min) [Time frame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days]
  • Collection of hemodynamic parameters (Blood Pressure in mmHg, Pulmonary Artery Pressure in mmHg, Central Venous Pressure in mmHg, Pulmonary Capillary Wedge Pressure in mmHg) [Time frame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days]
  • Collection of hemodynamic parameters (Mixed Venous Saturation in %) [Time frame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days]
  • Collection of hemodynamic parameters (Pulmonary Vascular Resistance in In dynes/sec/cm-5 ) [Time frame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days]
Secondary outcome measures (1)
  • Rate of Patient Survival [Time frame: Once the Impella support is permanently weaned, on average 2 days]

Eligibility criteria

Inclusion criteria

  • Ongoing or planned intensive care management with Impella support
  • Presence or planned placement of a cardiac output measurement
  • Preferentially pulmonary catheter (including cardiac output (CO) preferred as continuous measurement)
  • Other means of discontinuous CO measurement incl. echocardiography, other thermodilution methods

Exclusion criteria

  • Age < 18 years
  • Pregnancy
  • Anticipated support duration <24 h

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 2 centers
  • Uniklinik RWTH Aachen — Aachen
  • UKSH Campus Kiel — Kiel
Italy · 1 center
  • IRCCS Ospedale San Raffaele — Milan
Switzerland · 1 center
  • Universitätsspital Basel — Basel

Identifiers

NCT: NCT06308055 · 2022-R01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗