Development of Algorithms to Predict Hemodynamic Instability

February 18, 2016 updated by: Klinik für Kardiologie, Pneumologie und Angiologie

Development of Algorithms to Detect and Predict Hemodynamic Instability in Patients at Risk

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.

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Duesseldorf, NRW, Germany, 40225
        • Heinrich-Heine-University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients being at risk of sudden cardiac death

Description

Inclusion Criteria:

  • hospitalization
  • Age > 17 years

Exclusion Criteria:

  • documented diseases of the central nervous system
  • impairment of mental health
  • age > 85 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Risk Population
Patients being suspected to be at risk of hemodynamic instability due to medical history

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autonomic Dysfunction
Time Frame: 24 hours
Dysfunction of the autonomic nervous system as assessed by autonomic reflex testing
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Investigators

  • Study Chair: Christian Meyer, MD, University of Duesseldorf
  • Study Director: Malte Kelm, MD, PhD, University of Duesseldorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

December 16, 2010

First Submitted That Met QC Criteria

December 16, 2010

First Posted (Estimate)

December 17, 2010

Study Record Updates

Last Update Posted (Estimate)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 18, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Autonomics - Prediction

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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