Text Size

Does Modified Ultrafiltration Improves Inflammatory Response and Cardiopulmonary Function After CABG Procedures?

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01140113
First received: June 7, 2010
Last updated: June 8, 2010
Last verified: June 2010
History of Changes
  Purpose

The inflammatory response after cardiac surgery increases mortality and morbidity. Modified ultrafiltration (MUF) has been shown to decrease the post-cardiac surgery inflammatory response, to improve respiratory function, and cardiac performance in pediatric patients; however, this approach has not been well established in adults. The investigators therefore hypothesized that MUF can decrease the post-cardiac surgery inflammatory response and can improve cardiopulmonary function in adults.


Condition Intervention
Coronary Artery Disease
Cardiac Surgical Procedures
 Procedure: Modified Ultrafiltration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Modified Ultrafiltration Improves Inflammatory Response and Cardiopulmonary Function After CABG Procedures?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • Overall clinical improvement after cardiac surgeries. [ Time Frame: 30 day after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The treatment group has less inflammatory markers [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • The treatment group has improvements in the respiratory variables [ Time Frame: 30 ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: July 2007
Study Completion Date: March 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Placebo
this group had undergone to routine coronary artery bypass graft surgery
Experimental: Modified Ultrafiltration
patients after weaning from bypass were submitted to ultrafiltration
 Procedure: Modified Ultrafiltration
After weaning from bypass patients had undergone to modified ultrafiltration for 15 minutes with a filtration flow at 300 ml/min
Other Name: Ultrafiltration

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective patients to coronary artery bypass graft surgery
  • left ventricle ejection fraction higher than 40%

Exclusion Criteria:

  • renal impairment (serum creatinine higher than 1.7 mg%)
  • neoplasm
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140113

Locations
Brazil
Hospital da Clinicas
Campinas, Sao Paulo, Brazil, 13100000
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Orlando Petrucci, MD, PhD University of Campinas
  More Information

No publications provided by University of Campinas, Brazil

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Orlando Petrucci, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01140113     History of Changes
Other Study ID Numbers: Modified Ultrafiltration
Study First Received: June 7, 2010
Last Updated: June 8, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
hemoconcentration
ultrafiltration
coronary artery disease

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

ClinicalTrials.gov processed this record on May 23, 2013