Atrial FibrillationNCT00840918
Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery
A study testing Lidocaine in people with Atrial Fibrillation, run by The Cleveland Clinic at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteIndia
- Study dates
- Feb 2009to 15 Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-90 years old
- Scheduled for cardiac surgery requiring cardiopulmonary bypass
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Perioperative Intravenous Lidocaine on Postoperative Outcomes After Cardiac Surgery
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Lidocaine, Placebo
- Keywords
- Cardiac surgery, Lidocaine, Quality of life
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Intravenous Lidocaine Group - Lidocaine administered intravenously throughout surgery and during the 24 hours following surgery.
PlaceboOther
Placebo is administered intravenously throughout surgery and during the 24 hours following surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Intravenous Lidocaine group Receives: Drug: Lidocaine |
| Placebo | Placebo comparator | Intravenous placebo Group - Placebo is administered intravenously throughout surgery and during the 24 hours following surgery Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completion15 Dec 2014
- Study completion15 Dec 2014
Why it stopped: Problem with enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Grady, M.D., Principal investigator, The Cleveland ClinicDaniel I Sessler, M.D., Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840918
- Sponsor's protocol ID
- 08-861
- Status last verified
- Mar 2019
- First submitted
- 10 Feb 2009
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Intravenous Lidocaine on Postoperative Outcomes After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00840918
- Acronym / sponsor ID
- 08-861
- Conditions
- Atrial Fibrillation
- Keywords
- Cardiac surgery, Lidocaine, Quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Problem with enrollment
- Enrolment
- 123 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- 15 Dec 2014 (actual)
- Study completion
- 15 Dec 2014 (actual)
- First posted
- 11 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: LidocaineIntravenous Lidocaine group |
| Placebo | Placebo comparator | Other: PlaceboIntravenous placebo Group - Placebo is administered intravenously throughout surgery and during the 24 hours following surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-90 years old
- Scheduled for cardiac surgery requiring cardiopulmonary bypass
- Written informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineIntravenous Lidocaine Group - Lidocaine administered intravenously throughout surgery and during the 24 hours following surgery. | Drug | 1 |
| PlaceboPlacebo is administered intravenously throughout surgery and during the 24 hours following surgery | Other | Placebo |
Primary outcome
atrial fibrillation
Time frame: postoperatively
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
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.
Results and safety
The study was stopped early (reason given: Problem with enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Grady, M.D. principal investigator
The Cleveland Clinic
Daniel I Sessler, M.D. study chair
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine in people with Atrial Fibrillation, run by The Cleveland Clinic at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Problem with enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atrial fibrillation (time frame: postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.