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Coronary Artery DiseaseMUFNCT01864395

Clinical and Chemical Outcomes Following Cardiac Surgery: The Post-Operative Effects of MUF

A study testing Centrifugation Method, Online MUF and Offline MUF in people with Coronary Artery Disease and Anemia, run by University of Saskatchewan at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

It is hypothesized that on-line modified ultrafiltration (MUFF) post-cardiopulmonary bypass will result in improved patient outcomes over the 12-hour post-operative period as compared to control and off-line MUFF. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Coronary Artery Disease, Anemia
What is being tested?
Centrifugation Method, Online MUF and Offline MUF
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteCanada
Study dates
Jul 2013to Oct 2014
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • male and female
  • patient weighs 75 kg or smaller
  • 40-80 years of age
  • elective or urgent cardiac surgery

Who cannot join

  • emergent surgery
  • severe anemia
  • severe kidney dysfunction
  • ejection fraction of less than 30%

Trial locations and contacts

1 site in 1 country.

Erick D McNair, PhD contact

1-306-222-7403

erick.mcnair@usask.ca

Canada1 site
  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

    Erick D McNair, PhD, 1-306-222-7403, erick.mcnair@usask.ca

Other trials in Canada

About this study

Official title: Clinical and Chemical Outcomes Following Cardiac Surgery: The Post-Operative Effects of Modified Ultrafiltration (On-line MUF) and Off-line (MUF)

It is hypothesized that on-line modified ultrafiltration (MUFF) post-cardiopulmonary bypass will result in improved patient outcomes over the 12-hour post-operative period as compared to control and off-line MUFF.

Read the detailed description

Current practice in cardiac surgery requiring cardiopulmonary bypass (CPB) dictates the salvage of the residual circuit volume at the end of the procedure into an autologous recovery system. This system uses the centrifugation method (CF) to separate whole blood into red blood cells (RBCs) and plasma components (Sutton et al, 1993). The RBCs are then washed with normal saline and re-infused into the patient as needed while the plasma components are discarded.

While this technique produces a product with a high haemoglobin (Hb), the main disadvantage of this process is the loss of plasma protein and clotting factors (Samolyk et al, 2005).

The Modified Ultrafitration (MUF) is a standard of care technique that was originally used on pediatric patients undergoing cardiac surgery with CPB. Following CPB while the aorta is still cannulated, MUF uses an inline hemofilter to concentrate the patients total blood volume thereby increasing Hb, plasma proteins, systemic blood pressure, and cardiac index while decreasing cytokines and post-operative bleeding (Kiziltepe et al. 2001).

According to a task-force on evidence based surgery (the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesia) the use of modified ultrafiltration (online-MUF) is indicated for blood conservation and reduction of post-operative blood loss in adult cardiac operations using cardiopulmonary bypass (CPB) (Ferraris et al 2011). Moreover, Luciani et al. 2001, showed significantly lower levels of GI, neurologic and cardiac complications in patients who underwent on-line MUF following cardiac surgery as compared to those who did not. They also demonstrated a significantly lower mortality at 30 days follow-up in patients receiving online MUF as compared to control. Boodhwani et al. (2006) demonstrated that the use of online MUF was associated with a 0.72 unit reduction in blood transfused and a reduction of post-operative loss. The disadvantages to this technique are the time required (10-15 min), delays protamine administration, and the requirement of anaesthesia cooperation for pressure management. According to the Proceedings of the American Society of Extracorporeal Technology International Conf. March 9, 2013, online MUF works best and is recommended for smaller patients 75 kg or less because the effect of concentration of the blood volume is greater in smaller patients as compared to larger patients. In house data collected by our Department of Clinical Perfusion at the Royal University Hospital has demonstrated that 70% of the smaller patients undergoing cardiac surgery (mainly women) receive allogeneic transfusion peri- and post-operatively.

Off-line MUFF, another standard of care technique, is used after separation from CPB and decannulation. This technique uses a hemofilter to concentrate the residual CPB volume to produce a product which is more analogous to whole blood as compared to that processed by the CF method. Recently, our research group has shown that after 12-hours post-operatively patients' biochemical (total protein and albumin) and clinical parameters (vasoactive inotrope score and fluid balance) were significantly improved when patients' residual CPB volume underwent multiple-pass hemofiltration as compared to the CF (McNair et al. (2013), Journal of Cardiothoracic and Vascular Anaesthesia, In Press). Recently, it has been demonstrated that following cardiac surgery, the post-operative use of vasoactive inotropes is decreased when the residual CPB volume is processed by the offline MUF method as compared to the CF method (Coli et al 2012; McNair et al. (2013), Journal of Cardiothoracic and Vascular Anaesthesia, In Press). The disadvantages of on-line MUFF are the possible entrainment of air into the arterial line and prolonged time for protamine administration. The disadvantages of off-line MUFF are inadequate clearance of heparin by the hemofilter and prolonged processing time.

There is a need for the proposed study because it will help to determine whether there is any difference in patient outcomes between the use of on-line MUF and off-line MUF. Our study will also demonstrate which method is better at enhancing clinical (volume of allogeneic transfusion, chest tube loss, fluid balance length of stay and ventilation time) and biochemical (Hb, total protein, albumin and markers of inflammation) outcomes during the 12-hour post-operative period.

The data gathered from this study may save smaller patients from exposure to allogeneic transfusions during the 12-hour postoperative period. This study will also determine which method our institution will use to better serve our patients, allowing them to have a safer, shorter, transfusion-free recovery during the post-operative period.

Being tested
Centrifugation Method, Online MUF, Offline MUF
Keywords
cardiovascular surgery, cardiac surgery, cardiopulmonary bypass, IV fluids, blood pressure, heart-lung machine, hemofilter, online MUF, offline MUF, modified ultrafiltration, multiple-pass hemofiltration, centrifugation method, blood transfusion, plasma proteins, post-cardiopulmonary bypass, hemoglobin, clotting factors, systemic blood pressure, cardiac index, cytokines
Medical subject headings
Coronary Artery Disease, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Centrifugation MethodProcedure or surgery

    Currently used to separate whole blood into red blood cells (RBCs) and plasma components. The RBCs are washed with normal saline and re-infused into the patient, while the plasma portion is discarded.

  • Online MUFProcedure or surgery

    Hemofilter is used online while the heart-lung machine is connected to the patient.

  • Offline MUFProcedure or surgery

    Hemofilter is used offline when the heart-lung machine is not connected to the patient.

Study groups in NCT01864395
Study groupRoleWhat they receive
Control (CF)ExperimentalCentrifugation Method (CF): currently used to separate whole blood into red blood cells (RBCs) and plasma components. The RBCs are washed with normal saline and re-infused into the patient, while the plasma portion is discarded.
Receives: Procedure: Centrifugation Method
Online MUFExperimentalOnline MUF: hemofilter is used online while the heart-lung machine is connected to the patient.
Receives: Procedure: Online MUF
Offline MUFExperimentalOffline MUF: hemofilter is used offline when the heart-lung machine is not connected to the patient.
Receives: Procedure: Offline MUF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-Operative Volume of Chest Tube Drainage

    Our primary outcome variable is the post-operative volume of chest tube drainage.

    Measured: 12 hours

Secondary outcomes (2)
  1. Biochemical Variables

    Biochemical variables include Hb, albumin fibrinogen, and total protein.

    Measured: 12 hours

  2. Clinical Variables

    Clinical variables include volume of allogeneic transfusion, length of stay in ICU, intubation time, and vasoactive inotrope score.

    Measured: 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionJul 2014 (estimated)
  4. Study completionOct 2014 (estimated)

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, Care provider
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01864395
Sponsor's protocol ID
13-143
Acronym
MUF
Status last verified
May 2013
First submitted
14 May 2013
Last updated
29 May 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Centrifugation Method, Online MUF and Offline MUF in people with Coronary Artery Disease and Anemia, run by University of Saskatchewan at 1 site in Canada.

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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 May 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 Canada. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Erick D McNair, PhD (1-306-222-7403, erick.mcnair@usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-Operative Volume of Chest Tube Drainage (time frame: 12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 May 2013.

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