Development of Algorithms to Predict Hemodynamic Instability

Completed

• Conditions: Sudden Cardiac Death

• Registration Number: NCT01262508
• Lead Sponsor: Klinik für Kardiologie, Pneumologie und Angiologie

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

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-12-16
• Study First Submitted QC: 2010-12-16
• Study First Posted: 2010-12-17
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• hospitalization
• Age > 17 years

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Autonomic Dysfunction	24 hours	Dysfunction of the autonomic nervous system as assessed by autonomic reflex testing

Secondary Outcome Measures

Name	Time	Method
Hemodynamic Deterioration	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

Trial Locations

Locations (1)

Heinrich-Heine-University; 🇩🇪 Duesseldorf, NRW, Germany