Hypertonic Solution in Off Pump Coronary Artery Bypass Graft Surgery
Recruitment status was Recruiting
This is a comparison between Hypertonic versus isotonic solution in a double blind randomized trial for off pump Coronary Artery Bypass Graft (CABG) surgery targeting the left marginal branch.
Hypertonic solution should provide better tolerance for heart mobilization with less volume expansion and less drugs.
Coronary Artery Disease
Drug: Hypertonic solution
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Use of Hypertonic Versus Isotonic Solutions in Off Pump Coronary Artery Bypass Graft Surgery Targeting the Left Marginal Branch|
- Use of vasoactive drugs in left marginal branch off pump CABG surgery [ Time Frame: time related to left branch coronary anastomosis for drug need. ] [ Designated as safety issue: No ]Comparison between hypertonic and isotonic solutions for need of vasoactive drugs with heart mobilization during left marginal branch off pump CABG surgery. Data will be collected respectively at 1, 5 and 10 minutes after beggining the left branch coronary anastomosis. Data will be type of drug need and dosage until the end os the anastomosis.
- Fluid balance [ Time Frame: Operative period and first operative day ] [ Designated as safety issue: No ]Comparison of fluid balance in the operative period between hypertonic and isotonic solutions. Data will be collected at the end of surgery and by next mornning.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||April 2012|
|Estimated Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Hypertonic
Use of Hypertonic solution during left marginal branch CABG surgery.
Drug: Hypertonic solution
Use of Hypertonic solution 4 ml/Kg during left marginal branch CABG surgery.
Placebo Comparator: Isotonic
Use of Isotonic solution during left marginal branch CABG surgery.
Use of Isotonic solution 4 ml/Kg during left marginal branch CABG surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463917
|Contact: Roberto R Silva, MD PHDfirstname.lastname@example.org|
|Jundiai, Sao Paulo, Brazil, 1295|
|Contact: Ricardo De Mola, MD 55-11-45276226 email@example.com|
|Sub-Investigator: Ricardo De Mola, MD|
|Principal Investigator:||ROBERTO R Silva, MD PHD||Hospital Pitangueiras|