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Hypertonic Solution in Off Pump Coronary Artery Bypass Graft Surgery

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Hypertonic solution
Isotonic
Sponsored by
Hospital Pitangueiras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Bypass, Off-Pump, Saline Solution, Hypertonic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Off pump CABG targeting the left marginal branch

Exclusion Criteria:

  • On pump surgery

Sites / Locations

  • Hospital PitangueirasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hypertonic

Isotonic

Arm Description

Use of Hypertonic solution during left marginal branch CABG surgery.

Use of Isotonic solution during left marginal branch CABG surgery.

Outcomes

Primary Outcome Measures

Use of vasoactive drugs in left marginal branch off pump CABG surgery
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
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.

Full Information

First Posted
October 19, 2011
Last Updated
October 31, 2011
Sponsor
Hospital Pitangueiras
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1. Study Identification

Unique Protocol Identification Number
NCT01463917
Brief Title
Hypertonic Solution in Off Pump Coronary Artery Bypass Graft Surgery
Official Title
Use of Hypertonic Versus Isotonic Solutions in Off Pump Coronary Artery Bypass Graft Surgery Targeting the Left Marginal Branch
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
April 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Pitangueiras

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Bypass, Off-Pump, Saline Solution, Hypertonic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypertonic
Arm Type
Active Comparator
Arm Description
Use of Hypertonic solution during left marginal branch CABG surgery.
Arm Title
Isotonic
Arm Type
Placebo Comparator
Arm Description
Use of Isotonic solution during left marginal branch CABG surgery.
Intervention Type
Drug
Intervention Name(s)
Hypertonic solution
Intervention Description
Use of Hypertonic solution 4 ml/Kg during left marginal branch CABG surgery.
Intervention Type
Drug
Intervention Name(s)
Isotonic
Intervention Description
Use of Isotonic solution 4 ml/Kg during left marginal branch CABG surgery.
Primary Outcome Measure Information:
Title
Use of vasoactive drugs in left marginal branch off pump CABG surgery
Description
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.
Time Frame
time related to left branch coronary anastomosis for drug need.
Secondary Outcome Measure Information:
Title
Fluid balance
Description
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.
Time Frame
Operative period and first operative day

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Off pump CABG targeting the left marginal branch Exclusion Criteria: On pump surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto R Silva, MD PHD
Phone
55-11-45215757
Email
rochaesilva@incor.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ROBERTO R Silva, MD PHD
Organizational Affiliation
Hospital Pitangueiras
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Pitangueiras
City
Jundiai
State/Province
Sao Paulo
ZIP/Postal Code
1295
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo De Mola, MD
Phone
55-11-45276226
Email
ricardo_485@terra.com.br
First Name & Middle Initial & Last Name & Degree
Ricardo De Mola, MD

12. IPD Sharing Statement

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Hypertonic Solution in Off Pump Coronary Artery Bypass Graft Surgery

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