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
Sponsor:
Information provided by (Responsible Party):
Roberto Rocha e Silva, Hospital Pitangueiras
ClinicalTrials.gov Identifier:
NCT01463917
First received: October 19, 2011
Last updated: October 31, 2011
Last verified: October 2011
  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
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: 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
Study First Received: October 19, 2011
Last Updated: October 31, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Hospital Pitangueiras:
Coronary Artery Bypass
Off-Pump
Saline Solution
Hypertonic

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

ClinicalTrials.gov processed this record on October 23, 2014