Heart Rate Variability Changes During Cardiac Surgery And The Incidence Of Post-Operative Cardiac Arrhythmias

Cardiac Arrhythmia Clinical Trial

Official title:

Heart Rate Variability Changes During Cardiac Surgery And The Incidence Of Post-Operative Cardiac Arrhythmias

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01359683
• Other study ID #: 17028
• Status: Withdrawn
• Phase: N/A
• First received: April 7, 2008
• Last updated: June 12, 2013
• Start date: September 2007

Study information

• Verified date: April 2008
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate non-linear heart rate variability indexes as predictors of the incidence of cardiac arrhythmias in patients undergoing cardiac surgery, including coronary artery bypass graft (CABG) and valvular surgery.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients who will have cardiac surgery

• The patient must be mentally able and willing to participate in the study

• Male or female patients over the age of 18

Exclusion Criteria:

• Patients with major renal, hepatic, respiratory, or cerebral dysfunction

• Patients with atrial fibrillation or other forms of sinus node dysfunction

• Patients requiring continuous artificial pacing

• Patients with significant congenital heart disease with or without arrhythmias

• Patients on Intra-Aortic Balloon Pump

• Patients experiencing cardiac emergencies or undergoing cardiac salvage operations

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

Device:
• Dataq Instruments DI-158
Data Acquisition Device (connects to room instrumentation)

Locations

Country	Name	City	State
United States	Hahnemann University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Drexel University College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate non-linear heart rate variability (HRV) indexes as predictors of the incidence of cardiac arrhythmias in patients undergoing cardiac surgery, including coronary artery bypass graft (CABG) and valvular surgery.		Sept 07 - Sept 08	No
Secondary	Registration of HRV changes during cardiac surgery, and comparison HRV pre-operatively, post anesthesia induction, on emergence from anesthesia and postoperatively.		Sept 07 - Sept 08	No