Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery

NCT00840918 | Terminated DMC

• 1 other identifier: 08-861
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

Cardiac surgery; Lidocaine; Quality of life

Outcome Measures

Primary Outcomes (2)

• atrial fibrillation

  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.

  postoperatively

• mortality

  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.

  30 days post surgery

Study Arms (2)

1

ACTIVE COMPARATOR

Intravenous Lidocaine group

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

Intravenous placebo Group - Placebo is administered intravenously throughout surgery and during the 24 hours following surgery

Other: Placebo

Interventions

Lidocaine DRUG

Intravenous Lidocaine Group - Lidocaine administered intravenously throughout surgery and during the 24 hours following surgery.

1

Placebo OTHER

Placebo is administered intravenously throughout surgery and during the 24 hours following surgery

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

SAL Hospital

Ahmedabad, Gujarat, 380 054, India

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Martin Grady, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Daniel I Sessler, M.D.

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2009
• First Posted: February 11, 2009
• Study Start: February 1, 2009
• Primary Completion: December 15, 2014
• Study Completion: December 15, 2014
• Last Updated: March 29, 2019

Record last verified: 2019-03

Locations

IN (1)