Phase 2 N=448 Randomized Supportive Care

Myocardial Protection With Multiport Antegrade Cold Blood Cardioplegia

Coronary Artery Bypass Surgery

Bottom Line

View on ClinicalTrials.gov: NCT02303704 ↗

Enrolled (actual)

448

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcome: Primary: Post-op CK-MB Levels — 71.70; 92.66 IU/L — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: multiport antegrade cardioplegia (Procedure); Aortic root antegrade cardioplegia (Procedure)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Chaudhry Pervaiz Elahi Institute of Cardiology
Primary completion: Jun 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Post-op CK-MB Levels	71.70; 92.66	<0.05 sig
SECONDARY Pharmacologic Inotropic Support (Adrenaline)	0.047; 0.064	<0.05 sig
SECONDARY Pharmacological Inotropic Support (Nor-adrenaline)	0.035; 0.089	<0.05 sig
SECONDARY Pharamacological Inotropic Support (Dobutamine)	3.41; 4.20	<0.05 sig
SECONDARY Intra-aortic Balloon Pump Counter-pulsation (IABPC) Support	4; 14	<0.05 sig
SECONDARY Operative Mortality	1; 9	<0.05 sig

Summary

In spite improvements in methods of myocardial protection, peri-operative myocardial damage is still the commonest cause of early morbidity and mortality after technically successful CABG Surgery. What is the optimum method of myocardial protection is still debatable. The investigators conducted this study to see effects of multiport antegrade cold blood cardioplegia on myocardial protection, along with continuous controlled warm blood perfusion through veins graft during proximal ends anastomosis in conventional CABG surgery in patients having multi-vessel disease.

Eligibility Criteria

Inclusion Criteria

All patients undergoing isolated conventional CABG were included in the study

Exclusion Criteria

The redo CABG surgery. Those who required 2 or less than 2 grafts. Patients who had major postoperative neurological complications like stroke. 2nd arterial graft along with LIMA. Patients who need CABG within a week of STEMI or NSTEMI. Patients with calcified or diseased aorta in which single cross clamp technique was used for proximal aorto-coronary anastomosis

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Data sourced from ClinicalTrials.gov (NCT02303704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.