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.
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.
Canada1 site
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Erick D McNair, PhD, 1-306-222-7403, erick.mcnair@usask.ca
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.
- Conditions
- Coronary Artery Disease, Anemia
- 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 group | Role | What they receive |
|---|---|---|
| Control (CF) | Experimental | Centrifugation 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 MUF | Experimental | Online MUF: hemofilter is used online while the heart-lung machine is connected to the patient. Receives: Procedure: Online MUF |
| Offline MUF | Experimental | Offline 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.
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)
Biochemical Variables
Biochemical variables include Hb, albumin fibrinogen, and total protein.
Measured: 12 hours
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.
- First posted29 May 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erick D McNair, PhD, Principal investigator, Clinical Assistant Professor, Department of Surgery, Cardiovascular Surgery
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
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Chemical Outcomes Following Cardiac Surgery: The Post-Operative Effects of Modified Ultrafiltration (On-line MUF) and Off-line (MUF)
- ClinicalTrials.gov ID
- NCT01864395
- Acronym / sponsor ID
- MUF / 13-143
- Conditions
- Coronary Artery Disease, Anemia
- Keywords
- cardiovascular surgery, cardiac surgery, cardiopulmonary bypass, IV fluids, blood pressure, heart-lung machine, hemofilter, online MUF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 29 May 2013 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control (CF) | Experimental | Procedure: Centrifugation MethodCentrifugation 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. |
| Online MUF | Experimental | Procedure: Online MUFOnline MUF: hemofilter is used online while the heart-lung machine is connected to the patient. |
| Offline MUF | Experimental | Procedure: Offline MUFOffline MUF: hemofilter is used offline when the heart-lung machine is not connected to the patient. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male and female
- patient weighs 75 kg or smaller
- 40-80 years of age
- elective or urgent cardiac surgery
Key exclusion criteria (4 listed)
- emergent surgery
- severe anemia
- severe kidney dysfunction
- ejection fraction of less than 30%
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 |
|---|---|---|
| Centrifugation MethodCurrently 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. | Procedure or surgery | Control (CF) |
| Online MUFHemofilter is used online while the heart-lung machine is connected to the patient. | Procedure or surgery | Online MUF |
| Offline MUFHemofilter is used offline when the heart-lung machine is not connected to the patient. | Procedure or surgery | Offline MUF |
Primary outcome
Post-Operative Volume of Chest Tube Drainage
Time frame: 12 hours
Our primary outcome variable is the post-operative volume of chest tube drainage.
2 secondary outcomes
Biochemical Variables
Time frame: 12 hours
Clinical Variables
Time frame: 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
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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.
Erick D McNair, PhD principal investigator
Clinical Assistant Professor, Department of Surgery, Cardiovascular Surgery
1 site in 1 country: see every site and its status.
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.