Development of Algorithms to Predict Hemodynamic Instability

NCT01262508 | Completed

• 1 other identifier: Autonomics - Prediction
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sudden Cardiac Death

Keywords

autonomic nervous system

Outcome Measures

Primary Outcomes (1)

• Autonomic Dysfunction

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

  24 hours

Secondary Outcomes (1)

• Hemodynamic Deterioration

  24 hours

Study Arms (1)

Risk Population

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients being at risk of sudden cardiac death

You may qualify if:

• hospitalization
• Age \> 17 years

You may not qualify if:

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

Sponsors & Collaborators

• Klinik für Kardiologie, Pneumologie und Angiologie: lead

Study Sites (1)

Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Related Publications (2)

• 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.

  PMID: 26465747 DERIVED

• 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.

  PMID: 22826079 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

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

Study Officials

• Christian Meyer, MD

  University of Duesseldorf

  STUDY CHAIR

• Malte Kelm, MD, PhD

  University of Duesseldorf

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Klinik für Kardiologie, Pneumologie und Angiologie Christian Meyer, MD

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 17, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

DE (1)