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Mini Versus Conventional Cardiopulmonary Bypass In CABG in Asian Patients (MiniCPB)

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ClinicalTrials.gov Identifier: NCT03657225
Recruitment Status : Completed
First Posted : September 5, 2018
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
National University Hospital, Singapore

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Neurological Injury Device: Utilization of the mini CPB circuit Drug: Utilization of the conventional circuit Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison Of Mini-Bypass To Conventional Cardiopulmonary Bypass In Asian Patients Undergoing Coronary Artery Bypass Grafting Surgery
Study Start Date : November 2008
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2014
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Mini CPB (ECCO, Sorin, Italy)
Utilization of the mini CPB circuit (Extra Corporeal Circuit Optimized; Phisio, Sorin Group, Italy)
 Device: Utilization of the mini CPB circuit
Comparison of the mini CPB circuit to conventional circuit
Placebo Comparator: Conventional
Use of conventional CPB circuit
 Drug: Utilization of the conventional circuit
Comparison of the mini CPB circuit to conventional circuit


Outcome Measures
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Primary Outcome Measures :
  1. Acute kidney injury [ Time Frame: 48 hours after surgery ]
    Meeting AKIN 1 criteria


Secondary Outcome Measures :
  1. Neurocognitive decline [ Time Frame: 3 months post surgery ]
    Use of Neurocognitive test / questionnaire: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  2. Inflammation [ Time Frame: 72 hours post surgery ]
    Markers for inflammation will be measured preoperatively, and daily till the 3rd postoperative day, including TNF-alpha, IL-6 and C-Reactive Protein.


Other Outcome Measures:
  1. Atrial fibrillation [ Time Frame: 7 days post surgery ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • first time on pump CABG revascularization

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657225


Locations
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Singapore
National University Health System
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
National Medical Research Council (NMRC), Singapore
Investigators
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Principal Investigator: Lian K Ti, MBBS, MMed National University Health System, Singapore
More Information
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Publications:

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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT03657225    
Other Study ID Numbers: NHG DSRB 2008/00332
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018
Keywords provided by National University Hospital, Singapore:
miniaturized
cardiopulmonary bypass
Additional relevant MeSH terms:
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Trauma, Nervous System
Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
 Kidney Diseases
Urologic Diseases
Nervous System Diseases