The Del Nido Versus Cold Blood Cardioplegia in Aortic Valve Replacement

Not Applicable

Completed

• Conditions: Aortic Valve Disease; Ischemia-reperfusion Injury
• Interventions: Drug: del Nido cardioplegia; Drug: cold blood cardioplegia

• Registration Number: NCT03818126
• Lead Sponsor: Pawel Buszman

Brief Summary

A group of 150 patients undergoing aortic valve replacement procedure will be randomized either into del Nido cardioprotection protocol (75 participants) or into the cold blood cardioplegia protocol (75 participants).

The intraoperative and perioperative outcomes of using each solution will be presented and compared (see the endpoints).

Detailed Description

The del Nido cardioplegia was developed by Pedro del Nido and his team at the University of Pittsburgh in 1990s. It was primarily designed for children and it has been used in pediatric cardiac surgery in Boston's Children Hospital since 1994.

There are few studies regarding the del Nido cardioplegia. A prospective, randomized trial was designed to determine the efficiency of the del Nido cardioplegia when compared to multidose cold blood cardioplegia in cardiac procedures with short and moderate cross-clamp times.

For the analysis of two cardioprotection protocols, it is essential to compare groups equal in terms of the surgery and perioperative care, with the same surgical risk and cross-clamp time. The research required elimination of all the unnecessary variables.

The patients undergoing aortic valve replacement procedure were selected as a study population. A group of 150 patients will be randomized either into del Nido cardioprotection protocol (75 participants) or into the cold blood cardioplegia protocol (75 participants).

The intraoperative and perioperative outcomes of using each solution will be presented and compared (see the endpoints).

Study Timeline

• Study Start: 2016-07-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-07-31
• Status Verified: 2019-01
• Study First Submitted: 2019-01-20
• Study First Submitted QC: 2019-01-25
• Last Update Submitted: 2019-01-25
• Study First Posted: 2019-01-28
• Last Update Posted: 2019-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• qualification for isolated aortic valve replacement
• age>18 years
• given consent for the study

Exclusion Criteria

• reoperation
• allergy to lidocaine
• coronary artery disease requiring surgical or percutaneous intervention
• pregnancy
• ejection fraction<30%
• massive aortic calcification ("porcelain aorta")

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
del Nido cardioplegia	del Nido cardioplegia	-
cold blood cardioplegia	cold blood cardioplegia	-

Primary Outcome Measures

Name	Time	Method
Ventricular fibrillation during reperfusion	intraoperative	Ventricular fibrillation as first observed rhythm after removing the aortic cross-clamp
hs-TnT (High sensitivity troponin T) - 24 hours	24 hours postoperatively	High sensitivity troponin T measured 24 hours postoperatively
hs-TnT (High sensitivity troponin T) - 48 hours	48 hours postoperatively	High sensitivity troponin T measured 48 hours postoperatively
CK-MB (Creatine kinase- MB isoenzyme) - 24 hours	24 hours postoperatively	Creatine kinase (MB isoenzyme) measured 24 hours postoperatively
CK-MB (Creatine kinase- MB isoenzyme) - 48 hours	48 hours postoperatively	Creatine kinase (MB isoenzyme) measured 48 hours postoperatively
Electrical cardiac activity during cross-clamp	intraoperative	Electrical activity observed during the cardiac arrest (cross-clamp)

Secondary Outcome Measures

Name	Time	Method
Perioperative creatinine values	up to 2 weeks
Overall mortality	30 days postoperative
Ventricular fibrillation during the cardioplegia administration	intraoperative
Time from the beginning of cardioplegia administration to cardiac arrest	intraoperative
Procedural use of the pacemaker	intraoperative
Intraoperative myocardial infarction	intraoperative
Fall of ejection fraction (EF)	48 hours	5% fall in the EF
Inotrope administration	intraoperative, 48 hours
Use of the intraaortic balloon pump	intraoperative, 48 hours
Perioperative atrial fibrillation	up to 2 weeks
Perioperative arrhythmia (other than AF)	up to 2 weeks
Postoperative packed red blood cells transfusion	up to 2 weeks
Kidney injury	up to 2 weeks	The creatinine elevation \>25% or \>0.5mg/dl
CVVHDF	up to 2 weeks	Use of continous veno-venous hemodiafiltration
Cardiac death	30 days postoperative	death from cardiac reasons (e.g. myocardial infarction, low ejection fraction, arrhythmia).

Trial Locations

Locations (1)

1st Department of Cardiac Surgery; 🇵🇱 Bielsko-Biała, Poland