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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 (Responsible Party):
Orlando Petrucci, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01140113
First received: June 7, 2010
Last updated: July 21, 2013
Last verified: July 2013
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Modified Ultrafiltration Improves Inflammatory Response and Cardiopulmonary Function After CABG Procedures?

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall clinical improvement after cardiac surgeries. [ Time Frame: 30 day after surgery ]

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

Enrollment: 60
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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Orlando Petrucci, MD, PhD, 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: July 21, 2013

Keywords provided by Orlando Petrucci, 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 September 21, 2017