Clinical trial NCT01262508: Development of Algorithms to Predict Hemodynamic Instability
Official title: Development of Algorithms to Detect and Predict Hemodynamic Instability in Patients at Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sudden Cardiac Death
Keywords: autonomic nervous system
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2010-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients being at risk of sudden cardiac death

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

Eligibility criteria: Inclusion Criteria:

* hospitalization
* Age \> 17 years

Exclusion Criteria:

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

Primary outcomes:
measure: Autonomic Dysfunction
timeFrame: 24 hours
Secondary outcomes:
measure: Hemodynamic Deterioration
timeFrame: 24 hours
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Heinrich-Heine-University
state: NRW
Study officials:
affiliation: University of Duesseldorf
name: Christian Meyer, MD
role: STUDY_CHAIR
affiliation: University of Duesseldorf
name: Malte Kelm, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.