Development of Algorithms to Predict Hemodynamic Instability

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.

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Key information

Conditions

Sudden Cardiac Death Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, 40225, Germany

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

hospitalization
Age > 17 years

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Autonomic Dysfunction

Time frame: 24 hours

Dysfunction of the autonomic nervous system as assessed by autonomic reflex testing

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Dec 17, 2010
Registry last updated: Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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