Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Outcomes Research Consortium
Sponsor:
Information provided by (Responsible Party):
Martin Grady, Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00840918
First received: February 10, 2009
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

This study is being done to determine if lidocaine, administered during surgery and for 24 hours after surgery can reduce inflammation, thereby reducing the risk of atrial fibrillation and 30 day mortality after surgery. Participants undergoing cardiac surgery will be randomized to receive either lidocaine or placebo.


Condition Intervention
Atrial Fibrillation
Drug: Lidocaine
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Perioperative Intravenous Lidocaine on Postoperative Outcomes After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • atrial fibrillation [ Time Frame: postoperatively ] [ Designated as safety issue: No ]
    To test the hypothesis that lidocaine infusion started at induction of anesthesia and maintained for 24 hours postoperatively will decrease the incidence of atrial fibrillation compared to an intravenous saline control.

  • mortality [ Time Frame: 30 days post surgery ] [ Designated as safety issue: No ]
    To test the hypothesis that lidocaine infusion started at induction of anesthesia and maintained for 24 hours postoperatively will decrease the incidence of 30 day mortality as compared to an intravenous saline control.


Estimated Enrollment: 1294
Study Start Date: February 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Intravenous Lidocaine group
Drug: Lidocaine
Intravenous Lidocaine Group - Lidocaine administered intravenously throughout surgery and during the 24 hours following surgery.
Placebo Comparator: Placebo
Intravenous placebo Group - Placebo is administered intravenously throughout surgery and during the 24 hours following surgery
Other: Placebo
Placebo is administered intravenously throughout surgery and during the 24 hours following surgery

Detailed Description:

Subjects undergoing cardiac surgery are randomized into one of two groups.

  • Group 1: Intravenous Lidocaine Group
  • Group 2: Intravenous placebo Group

Either Lidocaine or placebo is administered throughout surgery and 24 hours after surgery.

Patients in both groups will undergo quality of life assessments and functional recovery assessments post-surgery.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-90 years old
  • Scheduled for cardiac surgery requiring cardiopulmonary bypass
  • Written informed consent

Exclusion Criteria:

  • Off-pump surgical procedures
  • Anticipated deep hypothermic circulatory arrest
  • Any contraindications to the proposed interventions including lidocaine allergy
  • History of preoperative atrial fibrillation
  • Baseline Screening revealing preexisting dementia or delirium
  • Preoperative liver failure defined as Child-Pugh Score > 6
  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: NCT00840918

Contacts
Contact: Gretchen Upton 216-444-3289 uptong@ccf.org

Locations
India
SAL Hospital Recruiting
Gujarat, Ahmedabad,, India, 380 054
Contact: Dhruti Trivedi    +91-79-4005 4103    dtrivedi@heartcareassociates.in   
Principal Investigator: Anil Jain, M.D.         
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Principal Investigator: Martin Grady, M.D. The Cleveland Clinic
Study Chair: Daniel I Sessler, M.D. The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Martin Grady, Principal Investigator, Outcomes Research Consortium
ClinicalTrials.gov Identifier: NCT00840918     History of Changes
Other Study ID Numbers: 08-861
Study First Received: February 10, 2009
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
Cardiac surgery
Lidocaine
Quality of life

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 26, 2014