Acute Kidney InjuryMiniCPBNCT03657225
Mini Versus Conventional Cardiopulmonary Bypass In CABG in Asian Patients
A study testing Utilization of the mini CPB circuit and Utilization of the conventional circuit in people with Acute Kidney Injury and Neurological Injury, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Our intention is to perform a randomized controlled trial to compare the efficacy and safety of mini cardiopulmonary bypass system to a modified conventional bypass circuit in 80 Asian patients undergoing elective CABG. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Acute Kidney Injury, Neurological Injury
- What is being tested?
- Utilization of the mini CPB circuit and Utilization of the conventional circuit
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2008to Jul 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first time on pump CABG revascularization
Who cannot join
- poor left ventricular ejection faction (< 30%)
- immunologic disease or malignancies
- acute inflammatory disease
- coagulopathy
- steroid treatment
- preoperative renal failure (currently receiving dialysis)
- significant carotid disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of Mini-Bypass To Conventional Cardiopulmonary Bypass In Asian Patients Undergoing Coronary Artery Bypass Grafting Surgery
Our intention is to perform a randomized controlled trial to compare the efficacy and safety of mini cardiopulmonary bypass system to a modified conventional bypass circuit in 80 Asian patients undergoing elective CABG. Our intend is to confirm the efficacy of mini-bypass in reducing haemodilution and reducing blood transfusions, and investigate if this is associated with reduced inflammation and better cardiovascular, neurological, renal, respiratory and infection outcome.
Read the detailed description
Mini-bypass systems have the potential to reduce the problems associated with conventional cardiopulmonary bypass systems by preserving hematocrit, reducing transfusion requirements, and reducing inflammation. Intuitively, this system would be ideal for our smaller Asian patients, who as a result of their body sizes, are prone to severe hemodilution and increased transfusion requirements. However, our initial results based on established Western protocols were not as good as the investigators hoped. Using a modified protocol, the investigators were able to reduce perioperative blood transfusion. Therefore, the investigators intend to prospectively confirm the efficacy of mini-bypass in conjunction with our modified protocol in reducing haemodilution and reducing blood transfusions. The investigators will also establish the safety of this protocol, and investigate if this is associated with reduced inflammation and better cardiovascular, neurological, renal, respiratory and infection outcomes.
80 Asian patients undergoing primary coronary artery bypass grafting with cardiopulmonary bypass will be randomly divided either to utilize the mini-bypass system (Extra Corporeal Circuit Optimized; Phisio, Sorin Group, Italy) or the conventional system. Anaesthesia, surgical and perfusion management will be standardized, except for measures specific to the establishment of mini-bypass. The primary outcome measures will be haemodilution (first and lowest hematocrit) during cardiopulmonary bypass, blood loss in the first 24 and 48 hours post-operatively, and perioperative blood transfusions. Secondary outcomes include safety profile (air embolization, hypoperfusion), inflammation (TNF-alpha, interleukin-6, C-reactive protein, lactate dehydrogenase) in the first 72 hours after bypass, clinical outcomes (renal, neurological, cardiac, respiratory) and resource utilization (blood utilization, length of stay).
This project will allow us to confirm our retrospective findings that mini-bypass systems in conjunction with our modified protocol will benefit our smaller patients haematologically and lead to tremendous savings in blood utilization. The investigators will also establish if this protocol is safe, and if there are additional benefits in terms of inflammation, clinical outcomes and resource utilization. Our findings will also be applicable throughout East Asia, as patients in the region generally lag our Western counterparts in size.
- Conditions
- Acute Kidney Injury, Neurological Injury
- Being tested
- Utilization of the mini CPB circuit, Utilization of the conventional circuit
- Keywords
- miniaturized, cardiopulmonary bypass
- Medical subject headings
- Acute Kidney Injury, Trauma, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utilization of the mini CPB circuitDevice
Comparison of the mini CPB circuit to conventional circuit
Utilization of the conventional circuitDrug
Comparison of the mini CPB circuit to conventional circuit
| Study group | Role | What they receive |
|---|---|---|
| Mini CPB (ECCO, Sorin, Italy) | Active comparator | Utilization of the mini CPB circuit (Extra Corporeal Circuit Optimized; Phisio, Sorin Group, Italy) Receives: Device: Utilization of the mini CPB circuit |
| Conventional | Placebo comparator | Use of conventional CPB circuit Receives: Drug: Utilization of the conventional circuit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
Meeting AKIN 1 criteria
Measured: 48 hours after surgery
Secondary outcomes (2)
Neurocognitive decline
Use of Neurocognitive test / questionnaire: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Measured: 3 months post surgery
Inflammation
Markers for inflammation will be measured preoperatively, and daily till the 3rd postoperative day, including TNF-alpha, IL-6 and C-Reactive Protein.
Measured: 72 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study startNov 2008
- Primary completionJul 2013
- Study completionJul 2014
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 Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Sponsor
- Investigators
- Lian K Ti, MBBS, MMed, Principal investigator, National University Health System, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657225
- Sponsor's protocol ID
- NHG DSRB 2008/00332
- Acronym
- MiniCPB
- Status last verified
- Aug 2018
- First submitted
- 1 Sep 2014
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ti LK, Goh BL, Wong PS, Ong P, Goh SG, Lee CN. Comparison of mini-cardiopulmonary bypass system with air-purge device to conventional bypass system. Ann Thorac Surg. 2008 Mar;85(3):994-1000. doi: 10.1016/j.athoracsur.2007.09.001.
PubMed 18291186
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Mini-Bypass To Conventional Cardiopulmonary Bypass In Asian Patients Undergoing Coronary Artery Bypass Grafting Surgery
- ClinicalTrials.gov ID
- NCT03657225
- Acronym / sponsor ID
- MiniCPB / NHG DSRB 2008/00332
- Conditions
- Acute Kidney Injury, Neurological Injury
- Keywords
- miniaturized, cardiopulmonary bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- Nov 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Sep 2018 (actual)
- 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.
Our intention is to perform a randomized controlled trial to compare the efficacy and safety of mini cardiopulmonary bypass system to a modified conventional bypass circuit in 80 Asian patients undergoing elective CABG. Our intend is to confirm the efficacy of mini-bypass in reducing haemodilution and reducing blood transfusions, and investigate if this is associated with reduced inflammation and better cardiovascular, neurological, renal, respiratory and infection outcome.
Detailed description
Mini-bypass systems have the potential to reduce the problems associated with conventional cardiopulmonary bypass systems by preserving hematocrit, reducing transfusion requirements, and reducing inflammation. Intuitively, this system would be ideal for our smaller Asian patients, who as a result of their body sizes, are prone to severe hemodilution and increased transfusion requirements. However, our initial results based on established Western protocols were not as good as the investigators hoped. Using a modified protocol, the investigators were able to reduce perioperative blood transfusion. Therefore, the investigators intend to prospectively confirm the efficacy of mini-bypass in conjunction with our modified protocol in reducing haemodilution and reducing blood transfusions. The investigators will also establish the safety of this protocol, and investigate if this is associated with reduced inflammation and better cardiovascular, neurological, renal, respiratory and infection outcomes.
80 Asian patients undergoing primary coronary artery bypass grafting with cardiopulmonary bypass will be randomly divided either to utilize the mini-bypass system (Extra Corporeal Circuit Optimized; Phisio, Sorin Group, Italy) or the conventional system. Anaesthesia, surgical and perfusion management will be standardized, except for measures specific to the establishment of mini-bypass. The primary outcome measures will be haemodilution (first and lowest hematocrit) during cardiopulmonary bypass, blood loss in the first 24 and 48 hours post-operatively, and perioperative blood transfusions. Secondary outcomes include safety profile (air embolization, hypoperfusion), inflammation (TNF-alpha, interleukin-6, C-reactive protein, lactate dehydrogenase) in the first 72 hours after bypass, clinical outcomes (renal, neurological, cardiac, respiratory) and resource utilization (blood utilization, length of stay).
This project will allow us to confirm our retrospective findings that mini-bypass systems in conjunction with our modified protocol will benefit our smaller patients haematologically and lead to tremendous savings in blood utilization. The investigators will also establish if this protocol is safe, and if there are additional benefits in terms of inflammation, clinical outcomes and resource utilization. Our findings will also be applicable throughout East Asia, as patients in the region generally lag our Western counterparts in size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini CPB (ECCO, Sorin, Italy) | Active comparator | Device: Utilization of the mini CPB circuitUtilization of the mini CPB circuit (Extra Corporeal Circuit Optimized; Phisio, Sorin Group, Italy) |
| Conventional | Placebo comparator | Drug: Utilization of the conventional circuitUse of conventional CPB circuit |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- first time on pump CABG revascularization
Key exclusion criteria (7 listed)
- poor left ventricular ejection faction (< 30%)
- immunologic disease or malignancies
- acute inflammatory disease
- coagulopathy
- steroid treatment
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 |
|---|---|---|
| Utilization of the mini CPB circuitComparison of the mini CPB circuit to conventional circuit | Device | Mini CPB (ECCO, Sorin, Italy) |
| Utilization of the conventional circuitComparison of the mini CPB circuit to conventional circuit | Drug | Conventional |
Primary outcome
Acute kidney injury
Time frame: 48 hours after surgery
Meeting AKIN 1 criteria
2 secondary outcomes
Neurocognitive decline
Time frame: 3 months post surgery
Inflammation
Time frame: 72 hours post surgery
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 5 Sep 2018.
- Background: PubMed 18291186Ti LK, Goh BL, Wong PS, Ong P, Goh SG, Lee CN. Comparison of mini-cardiopulmonary bypass system with air-purge device to conventional bypass system. Ann Thorac Surg. 2008 Mar;85(3):994-1000. doi: 10.1016/j.athoracsur.2007.09.001.
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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.
Lian K Ti, MBBS, MMed principal investigator
National University Health System, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Utilization of the mini CPB circuit and Utilization of the conventional circuit in people with Acute Kidney Injury and Neurological Injury, run by National University Hospital, Singapore at 1 site in Singapore.
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 1 inclusion and 7 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 5 Sep 2018. 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 Singapore. 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. Some participants in this study may receive a placebo. 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?
Acute kidney injury (time frame: 48 hours 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 NCT03657225, 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 5 Sep 2018.