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Completed

NCT Number: NCT00481234

Heart Rate Variability for Prediction of Perioperative Events

Patients with underlying cardiovascular disease are at high risk of perioperative cardiovascular events and death. Hemodynamic variables are controlled by the autonomic nervous system reflected by Heart Rate Variability. To investigate whether differences of HRV parameters predict perioperative cardiovascular events.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

About this study

Hypotension and bradycardia following induction of anesthesia may result in insufficient organ perfusion. Patients with underlying cardiovascular disease are at high risk of perioperative cardiovascular events and death. Hemodynamic variables are controlled by the autonomic nervous system reflected by Heart Rate Variability (HRV). Several authors demonstrated depressed long-term HRV in patients with underlying cardiovascular disease. Depressed 24 hours HRV proved to be highly predictive for cardiovascular morbidity and mortality Recently, short-term analysis was demonstrated to be a reliable tool to predict hypotension after spinal anesthesia. No data are available, however, with respect to preoperative HRV values and incidence of postoperative cardiovascular events. To investigate the prognostic value of HRV in patients with underlying cardiovascular disease. Hypothesise i) differences in pre-operative HRV are present in patients with underlying cardiovascular disease, ii) depressed preoperative HRV indicates high risk of post-operative cardiac ischemia, iii) depressed preoperative HRV is associated with longer postoperative hospital stay and adverse cardiac events after hospital discharge.

First, patients are assigned to one of two groups depending on the presence or absence of postoperative cardiac ischemia; second, a predictive model will be built to confirm our findings prospectively in another group of patients.

Patients: 100 patients (ASA physical status class II - IV) scheduled for general anesthesia. Inclusion criteria:evidence of high perioperative cardiovascular risk based on the Revised Cardiac Risk Index (RCRI >3).Exclusion criteria: lack of sinus rhythm, emergency cases, postoperative admission to an intensive care unit and age under 18 years. Time and frequency domain parameters of HRV will be recorded at the day of surgery before induction of anesthesia. Cardiovascular events and outcome will be analyzed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with cardiovascular risk factors defined as Revised Cardiac Risk Index score <= 3 scheduled for general anesthesia

Exclusion criteria

  • Lack of sinus rhythm, emergency cases, age < 18 years

Treatment and study plan

Heart Rate Variability analysis

Device

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

Heart Rate Variability for Prediction of Incidence of Cardiac Ischemia and Cardiovascular Events After General Anesthesia in High Risk Patients

Important dates

Study start
2002
Study completion
2006
First posted
Jun 1, 2007
Registry last updated
Jun 1, 2007

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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