Does Modified Ultrafiltration Improves Inflammatory Response and Cardiopulmonary Function After CABG Procedures?
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Jul 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 7, 2010
CompletedFirst Posted
Study publicly available on registry
June 9, 2010
CompletedJuly 23, 2013
July 1, 2013
1 year
June 7, 2010
July 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall clinical improvement after cardiac surgeries.
30 day after surgery
Secondary Outcomes (2)
The treatment group has less inflammatory markers
30 days
The treatment group has improvements in the respiratory variables
30
Study Arms (2)
Placebo
NO INTERVENTIONthis group had undergone to routine coronary artery bypass graft surgery
Modified Ultrafiltration
EXPERIMENTALpatients after weaning from bypass were submitted to ultrafiltration
Interventions
After weaning from bypass patients had undergone to modified ultrafiltration for 15 minutes with a filtration flow at 300 ml/min
Eligibility Criteria
You may qualify if:
- elective patients to coronary artery bypass graft surgery
- left ventricle ejection fraction higher than 40%
You may not qualify if:
- renal impairment (serum creatinine higher than 1.7 mg%)
- neoplasm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital da Clinicas
Campinas, São Paulo, 13100000, Brazil
Related Publications (1)
Torina AG, Silveira-Filho LM, Vilarinho KA, Eghtesady P, Oliveira PP, Sposito AC, Petrucci O. Use of modified ultrafiltration in adults undergoing coronary artery bypass grafting is associated with inflammatory modulation and less postoperative blood loss: a randomized and controlled study. J Thorac Cardiovasc Surg. 2012 Sep;144(3):663-70. doi: 10.1016/j.jtcvs.2012.04.012. Epub 2012 May 9.
PMID: 22578899DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Orlando Petrucci, MD, PhD
University of Campinas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 7, 2010
First Posted
June 9, 2010
Study Start
July 1, 2007
Primary Completion
July 1, 2008
Study Completion
March 1, 2009
Last Updated
July 23, 2013
Record last verified: 2013-07