Development of Algorithms to Predict Hemodynamic Instability

Sudden Cardiac Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262508
• Other study ID #: Autonomics - Prediction
• Status: Completed
• Phase: N/A
• First received: December 16, 2010
• Last updated: February 18, 2016
• Start date: September 2010
• Est. completion date: April 2015

Study information

• Verified date: February 2016
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• hospitalization

• Age > 17 years

Exclusion Criteria:

• documented diseases of the central nervous system

• impairment of mental health

• age > 85 years

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Sudden Cardiac Death

Locations

Country	Name	City	State
Germany	Heinrich-Heine-University	Duesseldorf	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Klinik für Kardiologie, Pneumologie und Angiologie

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autonomic Dysfunction	Dysfunction of the autonomic nervous system as assessed by autonomic reflex testing	24 hours	No
Secondary	Hemodynamic Deterioration	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	No

External Links

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