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Hypertonic Solution in Off Pump Coronary Artery Bypass Graft Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Roberto Rocha e Silva, 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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 Roberto Rocha e Silva, 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. ]
    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 ]
    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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Off pump CABG targeting the left marginal branch

Exclusion Criteria:

  • On pump surgery
  Contacts and Locations
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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

Keywords provided by Roberto Rocha e Silva, Hospital Pitangueiras:
Coronary Artery Bypass
Saline Solution

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Pharmaceutical Solutions processed this record on May 25, 2017