Hypertonic Solution in Off Pump Coronary Artery Bypass Graft Surgery

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Drug: Hypertonic solution; Drug: Isotonic

• Registration Number: NCT01463917
• Lead Sponsor: Hospital Pitangueiras

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Status Verified: 2011-10
• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-31
• Last Update Submitted: 2011-10-31
• Study First Posted: 2011-11-02
• Last Update Posted: 2011-11-02
• Primary Completion: 2012-03
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Off pump CABG targeting the left marginal branch

Exclusion Criteria

• On pump surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypertonic	Hypertonic solution	Use of Hypertonic solution during left marginal branch CABG surgery.
Isotonic	Isotonic	Use of Isotonic solution during left marginal branch CABG surgery.

Primary Outcome Measures

Name	Time	Method
Use of vasoactive drugs in left marginal branch off pump CABG surgery	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

Name	Time	Method
Fluid balance	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.

Trial Locations

Locations (1)

Hospital Pitangueiras; 🇧🇷 Jundiai, Sao Paulo, Brazil