Coronary Artery DiseaseNCT01140113
Does Modified Ultrafiltration Improves Inflammatory Response and Cardiopulmonary Function After CABG Procedures?
A study testing Modified Ultrafiltration in people with Coronary Artery Disease and Cardiac Surgical Procedures, run by University of Campinas, Brazil at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Coronary Artery Disease, Cardiac Surgical Procedures
- What is being tested?
- Modified Ultrafiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2007to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective patients to coronary artery bypass graft surgery
- left ventricle ejection fraction higher than 40%
Who cannot join
- renal impairment (serum creatinine higher than 1.7 mg%)
- neoplasm
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Modified Ultrafiltration
- Keywords
- hemoconcentration, ultrafiltration, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified UltrafiltrationProcedure or surgery
Also called Ultrafiltration
After weaning from bypass patients had undergone to modified ultrafiltration for 15 minutes with a filtration flow at 300 ml/min
| Study group | Role | What they receive |
|---|---|---|
| Placebo | No intervention | this group had undergone to routine coronary artery bypass graft surgery |
| Modified Ultrafiltration | Experimental | patients after weaning from bypass were submitted to ultrafiltration Receives: Procedure: Modified Ultrafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall clinical improvement after cardiac surgeries.
Measured: 30 day after surgery
Secondary outcomes (2)
The treatment group has less inflammatory markers
Measured: 30 days
The treatment group has improvements in the respiratory variables
Measured: 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startJul 2007
- Primary completionJul 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Orlando Petrucci, University of Campinas, Brazil
- Investigators
- Orlando Petrucci, MD, PhD, Principal investigator, University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140113
- Sponsor's protocol ID
- Modified Ultrafiltration
- Status last verified
- Jul 2013
- First submitted
- 7 Jun 2010
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22578899
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Modified Ultrafiltration Improves Inflammatory Response and Cardiopulmonary Function After CABG Procedures?
- ClinicalTrials.gov ID
- NCT01140113
- Acronym / sponsor ID
- Modified Ultrafiltration
- Keywords
- hemoconcentration, ultrafiltration, coronary artery disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jul 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 9 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | No intervention | –this group had undergone to routine coronary artery bypass graft surgery |
| Modified Ultrafiltration | Experimental | Procedure: Modified Ultrafiltrationpatients after weaning from bypass were submitted to ultrafiltration |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective patients to coronary artery bypass graft surgery
- left ventricle ejection fraction higher than 40%
Key exclusion criteria (2 listed)
- renal impairment (serum creatinine higher than 1.7 mg%)
- neoplasm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified UltrafiltrationAlso: UltrafiltrationAfter weaning from bypass patients had undergone to modified ultrafiltration for 15 minutes with a filtration flow at 300 ml/min | Procedure or surgery | Modified Ultrafiltration |
Primary outcome
Overall clinical improvement after cardiac surgeries.
Time frame: 30 day after surgery
2 secondary outcomes
The treatment group has less inflammatory markers
Time frame: 30 days
The treatment group has improvements in the respiratory variables
Time frame: 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2013.
- Derived from this study: PubMed 22578899Torina 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orlando Petrucci, MD, PhD principal investigator
University of Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Ultrafiltration in people with Coronary Artery Disease and Cardiac Surgical Procedures, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall clinical improvement after cardiac surgeries. (time frame: 30 day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01140113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2013; AzTrials last refreshed its copy on 27 Oct 2026.