Mini Versus Conventional Cardiopulmonary Bypass In CABG in Asian Patients

Acute Kidney Injury Clinical Trial

— MiniCPB  

Official title:

Comparison Of Mini-Bypass To Conventional Cardiopulmonary Bypass In Asian Patients Undergoing Coronary Artery Bypass Grafting Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03657225
• Other study ID #: NHG DSRB 2008/00332
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: July 2014

Study information

• Verified date: August 2018
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

Inclusion Criteria:

• first time on pump CABG revascularization

Exclusion Criteria:

• poor left ventricular ejection faction (< 30%)

• immunologic disease or malignancies

• acute in?ammatory disease

• coagulopathy

• steroid treatment

• preoperative renal failure (currently receiving dialysis)

• significant carotid disease

Related Conditions & MeSH terms

• Acute Kidney Injury
• Neurological Injury
• Trauma, Nervous System
• Wounds and Injuries

Intervention

Device:
• Utilization of the mini CPB circuit
Comparison of the mini CPB circuit to conventional circuit

Drug:
• Utilization of the conventional circuit
Comparison of the mini CPB circuit to conventional circuit

Locations

Country	Name	City	State
Singapore	National University Health System	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	National Medical Research Council (NMRC), Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Atrial fibrillation		7 days post surgery
Primary	Acute kidney injury	Meeting AKIN 1 criteria	48 hours after surgery
Secondary	Neurocognitive decline	Use of Neurocognitive test / questionnaire: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	3 months post surgery
Secondary	Inflammation	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