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Hypertonic Solution in Off Pump Coronary Artery Bypass Graft Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Hospital Pitangueiras.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Roberto Rocha e Silva, Hospital Pitangueiras Identifier:
First received: October 19, 2011
Last updated: October 31, 2011
Last verified: October 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 Intervention Phase
Coronary Artery Disease
Drug: Hypertonic solution
Drug: Isotonic
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Hospital Pitangueiras:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 20
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)
Arms Assigned Interventions
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.
Drug: Isotonic
Use of Isotonic solution 4 ml/Kg during left marginal branch CABG surgery.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Off pump CABG targeting the left marginal branch

Exclusion Criteria:

  • On pump surgery
  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 identifier: NCT01463917

Contact: Roberto R Silva, MD PHD 55-11-45215757

Hospital Pitangueiras Recruiting
Jundiai, Sao Paulo, Brazil, 1295
Contact: Ricardo De Mola, MD    55-11-45276226   
Sub-Investigator: Ricardo De Mola, MD         
Sponsors and Collaborators
Hospital Pitangueiras
Principal Investigator: ROBERTO R Silva, MD PHD Hospital Pitangueiras
  More Information


Responsible Party: Roberto Rocha e Silva, Chief, Adult Heart Surgery, MD PHD in Cardiovascular Surgery, Hospital Pitangueiras Identifier: NCT01463917     History of Changes
Other Study ID Numbers: hypertonic off pump CABS
Study First Received: October 19, 2011
Last Updated: October 31, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Hospital Pitangueiras:
Coronary Artery Bypass
Saline Solution

Additional relevant MeSH terms:
Coronary Artery Disease
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses processed this record on March 03, 2015