Trial Outcomes & Findings for Myocardial Protection With Multiport Antegrade Cold Blood Cardioplegia (NCT NCT02303704)

Results Overview

CK-MB is a marker of Myocardial Damage.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

448 participants

Primary outcome timeframe

36 hours after surgery.

Results posted on

2021-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Multiport Antegrade Cardioplegia Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.	Aortic Root Antegrade Cardioplegia Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
Overall Study STARTED	220	228
Overall Study COMPLETED	215	219
Overall Study NOT COMPLETED	5	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Multiport Antegrade Cardioplegia Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.	Aortic Root Antegrade Cardioplegia Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
Overall Study Protocol Violation	5	9

Baseline Characteristics

Myocardial Protection With Multiport Antegrade Cold Blood Cardioplegia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multiport Antegrade Cardioplegia n=215 Participants Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts	Aortic Root Antegrade Cardioplegia n=219 Participants Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion	Total n=434 Participants Total of all reporting groups
Age, Continuous	54.97 years STANDARD_DEVIATION 8.44 • n=93 Participants	53.62 years STANDARD_DEVIATION 9.60 • n=4 Participants	54.29 years STANDARD_DEVIATION 9.06 • n=27 Participants
Sex: Female, Male Female	29 Participants n=93 Participants	27 Participants n=4 Participants	56 Participants n=27 Participants
Sex: Female, Male Male	186 Participants n=93 Participants	192 Participants n=4 Participants	378 Participants n=27 Participants

PRIMARY outcome

Timeframe: 36 hours after surgery.

Population: All patients in whom Peak CKMB levels were noted within 24 hours after surgery

CK-MB is a marker of Myocardial Damage.

Outcome measures

Outcome measures
Measure	Multiport Antegrade Cardioplegia n=215 Participants Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.	Aortic Root Antegrade Cardioplegia n=219 Participants Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
Post-op CK-MB Levels	71.70 IU/L Standard Deviation 41.50	92.66 IU/L Standard Deviation 88.10

SECONDARY outcome

Timeframe: Upto 1 week after sugery

Population: All patients in whom Adrenaline was used to wean off the patients from Cardiopulmonary Bypass.

The need, dose and duration of adrenaline infusion to maintain hemodynamic stability after surgery were noted.

Outcome measures

Outcome measures
Measure	Multiport Antegrade Cardioplegia n=215 Participants Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.	Aortic Root Antegrade Cardioplegia n=219 Participants Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
Pharmacologic Inotropic Support (Adrenaline)	0.047 ug/kg/min Standard Deviation 0.018	0.064 ug/kg/min Standard Deviation 0.82

SECONDARY outcome

Timeframe: Upto 1 week after sugery

Population: All patients in whom Nor-adrenaline was used to wean off the patients from Cardiopulmonary Bypass.

The need, dose and duration of Nor-adrenaline infusion to maintain hemodynamic stability after surgery.

Outcome measures

Outcome measures
Measure	Multiport Antegrade Cardioplegia n=215 Participants Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.	Aortic Root Antegrade Cardioplegia n=219 Participants Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
Pharmacological Inotropic Support (Nor-adrenaline)	0.035 ug/kg/min Standard Deviation 0.016	0.089 ug/kg/min Standard Deviation 0.50

SECONDARY outcome

Timeframe: Upto 1 week after sugery

Population: All patients in whom Dobutamine was used to wean off the patients from Cardiopulmonary Bypass.

The Need, Dose and duration of Dobutamine to maintain hemodynamic stability after surgery.

Outcome measures

Outcome measures
Measure	Multiport Antegrade Cardioplegia n=215 Participants Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.	Aortic Root Antegrade Cardioplegia n=219 Participants Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
Pharamacological Inotropic Support (Dobutamine)	3.41 ug/kg/min Standard Deviation 1.70	4.20 ug/kg/min Standard Deviation 2.24

SECONDARY outcome

Timeframe: 24 hours before surgery and upto 1 week of surgical procedure.

Population: All patients who underwent surgery and for whom IABP support was required.

The need of IABPC (mechanical support) before surgery or during weaning from Cardiopulmonary bypass and in ICU to assist in maintaining hemodynamics of the patient.

Outcome measures

Outcome measures
Measure	Multiport Antegrade Cardioplegia n=215 Participants Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.	Aortic Root Antegrade Cardioplegia n=219 Participants Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
Intra-aortic Balloon Pump Counter-pulsation (IABPC) Support	4 participants	14 participants

SECONDARY outcome

Timeframe: Within 30 days after surgical Procedure

Population: all patients who underwent surgery and monitored for death due to surgical complication.

Deaths due to surgical complication during or after surgery.

Outcome measures

Outcome measures
Measure	Multiport Antegrade Cardioplegia n=215 Participants Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.	Aortic Root Antegrade Cardioplegia n=219 Participants Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
Operative Mortality	1 participants	9 participants

Adverse Events

Multiport Antegrade Cardioplegia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Aortic Root Antegrade Cardioplegia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Muhammad Sher-i-Murtaza

Ch. Pervaiz Elahi Institute of Cardiology, Multan, Pakistan.

Phone: 0333-6107570

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place