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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier:
NCT01359683
First received: April 7, 2008
Last updated: June 12, 2013
Last verified: April 2008
  Purpose

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.


Condition Intervention
Cardiac Arrhythmia
Device: Dataq Instruments DI-158

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Heart Rate Variability Changes During Cardiac Surgery And The Incidence Of Post-Operative Cardiac Arrhythmias

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2007
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Data Acquisition Device (connects to room instrumentation)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359683

Locations
United States, Pennsylvania
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Drexel University College of Medicine
  More Information

No publications provided

Responsible Party: Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier: NCT01359683     History of Changes
Other Study ID Numbers: 17028
Study First Received: April 7, 2008
Last Updated: June 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014