Hypertonic Solution in Off Pump Coronary Artery Bypass Graft Surgery
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|ClinicalTrials.gov Identifier: NCT01463917|
Recruitment Status : Unknown
Verified October 2011 by Roberto Rocha e Silva, Hospital Pitangueiras.
Recruitment status was: Recruiting
First Posted : November 2, 2011
Last Update Posted : November 2, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Hypertonic solution Drug: Isotonic||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Use of Hypertonic Versus Isotonic Solutions in Off Pump Coronary Artery Bypass Graft Surgery Targeting the Left Marginal Branch|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||March 2012|
|Estimated Study Completion Date :||April 2012|
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.
- Use of vasoactive drugs in left marginal branch off pump CABG surgery [ Time Frame: time related to left branch coronary anastomosis for drug need. ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|