Development of Algorithms to Predict Hemodynamic Instability

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Heinrich-Heine University, Duesseldorf
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01262508
First received: December 16, 2010
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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.


Condition
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 ] [ Designated as safety issue: No ]
    Dysfunction of the autonomic nervous system as assessed by autonomic reflex testing


Secondary Outcome Measures:
  • Hemodynamic Deterioration [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients being at risk of sudden cardiac death

Criteria

Inclusion Criteria:

  • hospitalization
  • Age > 17 years

Exclusion Criteria:

  • documented diseases of the central nervous system
  • impairment of mental health
  • age > 85 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262508

Contacts
Contact: Christian Meyer, MD +49-211-8118800 Christian.Meyer@med.uni-duesseldorf.de

Locations
Germany
Heinrich-Heine-University Recruiting
Duesseldorf, NRW, Germany, 40225
Contact: Christian Meyer, MD    +49 211 8118800    Christian.Meyer@med.uni-duesseldorf.de   
Principal Investigator: Malte Kelm, MD, PhD         
Principal Investigator: Christian Meyer, MD         
Sponsors and Collaborators
Klinik für Kardiologie, Pneumologie und Angiologie
Investigators
Study Chair: Christian Meyer, MD University of Duesseldorf
Study Director: Malte Kelm, MD, PhD University of Duesseldorf
  More Information

Additional Information:
No publications provided by Heinrich-Heine University, Duesseldorf

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Klinik für Kardiologie, Pneumologie und Angiologie Christian Meyer, MD, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01262508     History of Changes
Other Study ID Numbers: Autonomics - Prediction
Study First Received: December 16, 2010
Last Updated: November 12, 2013
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Death
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014