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Clinical Trials/NCT00481234
NCT00481234
Completed
Not Applicable

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

University Hospital Schleswig-Holstein1 site in 1 country2,002 target enrollmentJune 2002

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia
Sponsor
University Hospital Schleswig-Holstein
Enrollment
2002
Locations
1
Status
Completed
Last Updated
18 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 2002
End Date
December 2006
Last Updated
18 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital Schleswig-Holstein

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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