Hypertonic Solution in Off Pump Coronary Artery Bypass Graft Surgery

NCT01463917 | Unknown Phase 4 DMC

• 1 other identifier: hypertonic off pump CABS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Bypass; Off-Pump; Saline Solution; Hypertonic

Outcome Measures

Primary Outcomes (1)

• 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.

  time related to left branch coronary anastomosis for drug need.

Secondary Outcomes (1)

• Fluid balance

  Operative period and first operative day

Study Arms (2)

Hypertonic

ACTIVE COMPARATOR

Use of Hypertonic solution during left marginal branch CABG surgery.

Drug: Hypertonic solution

Isotonic

PLACEBO COMPARATOR

Use of Isotonic solution during left marginal branch CABG surgery.

Drug: Isotonic

Interventions

Hypertonic solution DRUG

Use of Hypertonic solution 4 ml/Kg during left marginal branch CABG surgery.

Hypertonic

Isotonic DRUG

Use of Isotonic solution 4 ml/Kg during left marginal branch CABG surgery.

Isotonic

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Off pump CABG targeting the left marginal branch

You may not qualify if:

• On pump surgery

Sponsors & Collaborators

• Hospital Pitangueiras: lead

Study Sites (1)

Hospital Pitangueiras

Jundiaí, São Paulo, 1295, Brazil

RECRUITING

Related Publications (19)

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MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Hypertonic Solutions

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Solutions; Pharmaceutical Preparations

Study Officials

• ROBERTO R Silva, MD PHD

  Hospital Pitangueiras

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto R Silva, MD PHD

CONTACT

55-11-45215757; rochaesilva@incor.usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Adult Heart Surgery, MD PHD in Cardiovascular Surgery

Study Record Dates

• First Submitted: October 19, 2011
• First Posted: November 2, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: November 2, 2011

Record last verified: 2011-10

Locations

BR (1)