Does Modified Ultrafiltration Improves Inflammatory Response and Cardiopulmonary Function After CABG Procedures?
Primary Purpose
Coronary Artery Disease, Cardiac Surgical Procedures
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Modified Ultrafiltration
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring hemoconcentration, ultrafiltration, coronary artery disease
Eligibility 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
Sites / Locations
- Hospital da Clinicas
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Placebo
Modified Ultrafiltration
Arm Description
this group had undergone to routine coronary artery bypass graft surgery
patients after weaning from bypass were submitted to ultrafiltration
Outcomes
Primary Outcome Measures
Overall clinical improvement after cardiac surgeries.
Secondary Outcome Measures
The treatment group has less inflammatory markers
The treatment group has improvements in the respiratory variables
Full Information
NCT ID
NCT01140113
First Posted
June 7, 2010
Last Updated
July 21, 2013
Sponsor
University of Campinas, Brazil
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01140113
Brief Title
Does Modified Ultrafiltration Improves Inflammatory Response and Cardiopulmonary Function After CABG Procedures?
Official Title
Does Modified Ultrafiltration Improves Inflammatory Response and Cardiopulmonary Function After CABG Procedures?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Patient selection After Institutional Review Board approval, a prospective study was carried out with 60 consecutive patients underwent CABG cardiopulmonary bypass (CPB) in our institution. All patients signed a consent form before enrolled into the study. The patients were randomly assigned to a control group treated with no modified ultrafiltration (CO group) or to a treatment group with modified ultrafiltration (MUF group) after bypass period. The inclusion criteria were: patients aged from 30 to 70 years old, both genders, left ventricle ejection fraction higher than 39%, normal renal function, with or without diabetes, and who underwent CABG with no associate procedures. The exclusion criteria were: left ventricle ejection fraction lower than 39% and abnormal renal function (serum creatinine > 2.0 mg/dl, clearance lower than 45 mL/m in males or lower than 40 mL/m in females).
Surgical procedure:
After anesthesia induction, the patients were monitored using a continuous cardiac output catheter (Edwards Lifesciense, Irvine. USA), invasive arterial mean pressure catheter, and urine output catheter.
All patients were submitted to tepid bypass (32 o C) with a target flow of 2.4 L/min/m2. After CPB was established the aorta was cross clamped and the distal anastomoses were performed. The blood tepid cardioplegia were used during the cross clamp period. The clamp was released and a C-clamp was applied for the proximal anastomosis effectuation. After a proximal anastomosis complementation, the patients were weaned from the bypass. Following the CPB period the patients were randomly assigned to MUF group or CO group. All operations were performed by one surgeon (O.P.).
Modified Ultrafiltration. The ultrafiltration was performed in heparinized patients between the arterial and the venous tubings of the CPB circuit, using a H-500 filter (polyestersuphone) with an effective membrane area of 0.5 m2, pore size of 5 nm, prime volume of 34 ml, maximum transmembrane pressure of 400 mmHg, internal fiber diameter of 200 µm, and fiber thickness wall of 30 µm (Braile Biomedica, São José do Rio Preto, Brazil).
The blood flow through the filter was 300 ml/min, which as maintained by a roller pump on the inlet part of the filter. Suction was applied to the filtrate port to achieve a negative pressure of 100 mmHg. The process was carried out for 15 minutes in all patients who underwent MUF while the patients assigned to CO group were observed for 15 minutes.
The hemostasis was reviewed, a mediastinal drain was inserted, the patient was closed, and sent to the intensive care unit.
Blood sample, oxygen transport, and hemodynamic parameters regimen:
The hemodynamic and oxygen transport parameters such as cardiac output index, systemic vascular resistance index, pulmonary vascular resistance index, arterial mean pressure, oxygen delivery (DO2), oxygen consumption (VO2), oxygen index (OI), and alveolar-arterial gradient (A-aDO2) were recorded.
The oxygen index was calculated by the following equation: OI = (FiO2 X MAP)/PaO2. The A-aDO2 were calculated by the equation: A-aDO2 = 713 X FiO2 - PaO2 - PaCO2). Where FiO2 is inspired fraction of oxygen, MAP is mean airway pressure, PaO2 is partial pressure of oxygen in the arterial blood, and PaCO2 is partial pressure of carbon dioxide in the arterial blood.
Blood samples were collected from arterial line with heparin coated tubes for interleukin 6 (IL-6), P-selectin, E-selectin, and intercellular adhesion molecule (ICAM) determination at the following times: after induction of anesthesia, pre MUF after bypass, post MUF, 24 hours after surgery, and 48 hours after of surgery. Blood samples were centrifuged for 20 minutes at 4oC and the serum was aliquoted and stored at - 70oC. The inflammatory markers were measured using commercially available ELISA kits (R&D Systems, Abingdon, UK).
Clinical variables:
Patients demographic data and medical history were collected prospectively. Postoperative data such as ICU length of stay (days), hospital length of stay (days), total blood loss in 48 hours, units of red blood cell transfusions, serum creatinine, international normalized ratio for prothrombin time (INR), partial thromboplastin time ratio (PR), leukocytes count, serum lactate, and urea nitrogen (BUN) were also recorded.
Statistical analyzes The continuous variables were expressed as mean with one standard deviation, the categorical variables were expressed as frequency. All data were tested for normality and the necessary transformations were performed as necessary. The t test for unpaired samples was used for total bleeding and requirements of RBC units transfusion analysis. The two-way ANOVA was performed for intragroup, intergroup, and time/group interactions with Bonferroni post-hoc test (GraphPad Prism version 5.0 for Mac OS X. San Diego California. USA). The P-values < 0.05 were considered statistically significant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Cardiac Surgical Procedures
Keywords
hemoconcentration, ultrafiltration, coronary artery disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
No Intervention
Arm Description
this group had undergone to routine coronary artery bypass graft surgery
Arm Title
Modified Ultrafiltration
Arm Type
Experimental
Arm Description
patients after weaning from bypass were submitted to ultrafiltration
Intervention Type
Procedure
Intervention Name(s)
Modified Ultrafiltration
Other Intervention Name(s)
Ultrafiltration
Intervention Description
After weaning from bypass patients had undergone to modified ultrafiltration for 15 minutes with a filtration flow at 300 ml/min
Primary Outcome Measure Information:
Title
Overall clinical improvement after cardiac surgeries.
Time Frame
30 day after surgery
Secondary Outcome Measure Information:
Title
The treatment group has less inflammatory markers
Time Frame
30 days
Title
The treatment group has improvements in the respiratory variables
Time Frame
30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orlando Petrucci, MD, PhD
Organizational Affiliation
University of Campinas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital da Clinicas
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13100000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
22578899
Citation
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.
Results Reference
derived
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Does Modified Ultrafiltration Improves Inflammatory Response and Cardiopulmonary Function After CABG Procedures?
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