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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01463917
First Posted: November 2, 2011
Last Update Posted: November 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Roberto Rocha e Silva, Hospital Pitangueiras
  Purpose

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: Quadruple (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.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Off pump CABG targeting the left marginal branch

Exclusion Criteria:

  • On pump surgery
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Roberto R Silva, MD PHD 55-11-45215757 rochaesilva@incor.usp.br

Locations
Brazil
Hospital Pitangueiras Recruiting
Jundiai, Sao Paulo, Brazil, 1295
Contact: Ricardo De Mola, MD    55-11-45276226    ricardo_485@terra.com.br   
Sub-Investigator: Ricardo De Mola, MD         
Sponsors and Collaborators
Hospital Pitangueiras
Investigators
Principal Investigator: ROBERTO R Silva, MD PHD Hospital Pitangueiras
  More Information

Publications:

Responsible Party: Roberto Rocha e Silva, Chief, Adult Heart Surgery, MD PHD in Cardiovascular Surgery, Hospital Pitangueiras
ClinicalTrials.gov Identifier: NCT01463917     History of Changes
Other Study ID Numbers: hypertonic off pump CABS
First Submitted: October 19, 2011
First Posted: November 2, 2011
Last Update Posted: November 2, 2011
Last Verified: October 2011

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pharmaceutical Solutions