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Development of Algorithms to Predict Hemodynamic Instability

This study has been completed.
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf Identifier:
First received: December 16, 2010
Last updated: February 18, 2016
Last verified: February 2016
Hemodynamic monitoring in hospitalized patients is crucial since in clinical practice unexpected deterioration of cardiovascular function remains a serious problem and an important cause of death. Novel perspectives in reflex testing of the autonomic nervous system might be useful to protect some patients from cardiovascular events by detecting cardiovascular deteriorations. In addition, standard pulse oximetry in low acuity settings is nowadays predominately used to monitor peripheral oxygen saturation. Of note, there is evidence that additional analyses of pulse wave characteristics might be a valuable source of information to generate additional insights into the cardiorespiratory status of the patient. Herein, we aim to develop novel algorithms in order to protect in-hospital patients from cardiovascular events in consequence of hemodynamic instability in the future.

Sudden Cardiac Death

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development of Algorithms to Detect and Predict Hemodynamic Instability in Patients at Risk

Further study details as provided by Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Autonomic Dysfunction [ Time Frame: 24 hours ]
    Dysfunction of the autonomic nervous system as assessed by autonomic reflex testing

Secondary Outcome Measures:
  • Hemodynamic Deterioration [ Time Frame: 24 hours ]
    Acute hemodynamic changes (Blood pressure changes > 10 mm Hg, heart rate changes > 5 bpm both within 30 seconds) of a patient as assessed by hemodynamic monitoring

Enrollment: 60
Study Start Date: September 2010
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Risk Population
Patients being suspected to be at risk of hemodynamic instability due to medical history

Detailed Description:

70 datasets from hospitalized patients will be acquired in order to characterize the functional status of the autonomic nervous system as well as hemodynamics during baseline and during standard procedures including physical exercise testing and head-up tilt table testing.

Autonomic reflex testing:

  • Heart Rate Characteristics
  • Heart Rate Variability
  • Heart Rate Turbulence
  • Blood Pressure Variability
  • Baroreflex Sensitivity
  • Hyperoxic Chemoreflex Sensitivity

Hemodynamic Monitoring:

  • Heart Rate Trends
  • Blood Pressure Trends
  • Pulse Wave Characteristics
  • Cardiac Output
  • Peripheral Vascular Resistance
  • Context information

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients being at risk of sudden cardiac death

Inclusion Criteria:

  • hospitalization
  • Age > 17 years

Exclusion Criteria:

  • documented diseases of the central nervous system
  • impairment of mental health
  • age > 85 years
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Please refer to this study by its identifier: NCT01262508

Duesseldorf, NRW, Germany, 40225
Sponsors and Collaborators
Klinik für Kardiologie, Pneumologie und Angiologie
Study Chair: Christian Meyer, MD University of Duesseldorf
Study Director: Malte Kelm, MD, PhD University of Duesseldorf
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Klinik für Kardiologie, Pneumologie und Angiologie Christian Meyer, MD, Heinrich-Heine University, Duesseldorf Identifier: NCT01262508     History of Changes
Other Study ID Numbers: Autonomics - Prediction
Study First Received: December 16, 2010
Last Updated: February 18, 2016

Keywords provided by Heinrich-Heine University, Duesseldorf:
autonomic nervous system

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden processed this record on May 25, 2017