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WithdrawnNCT01359683Updated Jun 14, 2013

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

An interventional study of Dataq Instruments DI-158 in Cardiac Arrhythmia, sponsored by Drexel University College of Medicine. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-14.

Sponsored by Drexel University College of Medicine · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiac Arrhythmia

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03

In context

Arrhythmias, Cardiac

915 studies on the registry are indexed under Arrhythmias, Cardiac; 234 are open to participants now.

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Lead sponsor

Drexel University College of Medicine is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    A

    This is a prospective observational study. 100 patients in one arm scheduled for cardiac surgery will be enrolled. ECG tracings will be obtained when subject is at rest, in supine position, before induction of anesthesia (within 24 hours prior to induction), after induction of general anesthesia, right before emergence from anesthesia (or before transportation to the ICU if the subject remains intubated), and within 24 hours post-operatively; additional ECG readings may be obtained during the surgery if deemed necessary.

    Device: Dataq Instruments DI-158

Interventions

  • DeviceDataq Instruments DI-158

    Data Acquisition Device (connects to room instrumentation)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Sept 07 - Sept 08

Secondary outcomes

  1. Registration of HRV changes during cardiac surgery, and comparison HRV pre-operatively, post anesthesia induction, on emergence from anesthesia and postoperatively.

    Time frame: Sept 07 - Sept 08

07

Study locations

1 site
  • Hahnemann University Hospital
    Philadelphia, Pennsylvania 19102, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01359683
Lead sponsor
Drexel University College of Medicine
Responsible party
Sponsor
First posted
May 25, 2011
Start date
Sep 2007
Primary completion
Sep 2009
Last update
Jun 14, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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