AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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.

Brazil1 site
  • Hospital da Clinicas

    Campinas, São Paulo, 13100000

Other trials in Brazil

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 groups in NCT01140113
Study groupRoleWhat they receive
PlaceboNo interventionthis group had undergone to routine coronary artery bypass graft surgery
Modified UltrafiltrationExperimentalpatients 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.

  1. Overall clinical improvement after cardiac surgeries.

    Measured: 30 day after surgery

Secondary outcomes (2)
  1. The treatment group has less inflammatory markers

    Measured: 30 days

  2. 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.

  1. First posted9 Jun 2010 (estimated)
  2. Study startJul 2007
  3. Primary completionJul 2008
  4. Study completionMar 2009

Resources

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)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT01140113 | AzTrials