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

August 30, 2018 updated by: National University Hospital, Singapore

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 119074
        • National University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute kidney injury
Time Frame: 48 hours after surgery
Meeting AKIN 1 criteria
48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurocognitive decline
Time Frame: 3 months post surgery
Use of Neurocognitive test / questionnaire: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
3 months post surgery
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.
72 hours post surgery

Other Outcome Measures

Outcome Measure
Time Frame
Atrial fibrillation
Time Frame: 7 days post surgery
7 days post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Collaborators

National Medical Research Council (NMRC), Singapore

Investigators

  • Principal Investigator: Lian K Ti, MBBS, MMed, National University Health System, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

September 1, 2014

First Submitted That Met QC Criteria

August 30, 2018

First Posted (Actual)

September 5, 2018

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

August 30, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHG DSRB 2008/00332

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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