Development of Algorithms to Predict Hemodynamic Instability

NCT ID: NCT01262508

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2015-04-30

Brief Summary

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.

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

Conditions

Sudden Cardiac Death

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Risk Population

Patients being suspected to be at risk of hemodynamic instability due to medical history

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• hospitalization
• Age > 17 years

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Klinik für Kardiologie, Pneumologie und Angiologie

OTHER

Sponsor Role: lead

Responsible Party

Klinik für Kardiologie, Pneumologie und Angiologie

Klinik für Kardiologie, Pneumologie und Angiologie Christian Meyer, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christian Meyer, MD

Role: STUDY_CHAIR

University of Duesseldorf

Malte Kelm, MD, PhD

Role: STUDY_DIRECTOR

University of Duesseldorf

Locations

Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, Germany

Countries

Germany

References

Jungen C, Zeus T, Balzer J, Eickholt C, Petersen M, Kehmeier E, Veulemans V, Kelm M, Willems S, Meyer C. Left Atrial Appendage Closure Guided by Integrated Echocardiography and Fluoroscopy Imaging Reduces Radiation Exposure. PLoS One. 2015 Oct 14;10(10):e0140386. doi: 10.1371/journal.pone.0140386. eCollection 2015.

Reference Type: DERIVED

PMID: 26465747 (View on PubMed)

Drexel T, Eickholt C, Muhlsteff J, Ritz A, Siekiera M, Kirmanoglou K, Schulze V, Shin DI, Balzer J, Rassaf T, Kelm M, Meyer C. Vagal heart rate control in patients with atrial fibrillation: impact of tonic activation of peripheral chemosensory function in heart failure. Adv Exp Med Biol. 2013;755:287-97. doi: 10.1007/978-94-007-4546-9_37.

Reference Type: DERIVED

PMID: 22826079 (View on PubMed)

Related Links

http://www.uniklinik-duesseldorf.de/kardiologie

Related Info

Other Identifiers

Autonomics - Prediction

Identifier Type: -

Identifier Source: org_study_id