ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01140113
Recruitment Status : Completed
First Posted : June 9, 2010
Last Update Posted : July 23, 2013
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Orlando Petrucci, University of Campinas, Brazil

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Cardiac Surgical Procedures Procedure: Modified Ultrafiltration Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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?
Study Start Date : July 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 9, 2010    Key Record Dates
Last Update Posted: July 23, 2013
Last Verified: July 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