The Del Nido Versus Cold Blood Cardioplegia in Aortic Valve Replacement

Pawel Buszman

Status: Completed

Conditions: Aortic Valve Disease; Ischemia-reperfusion Injury

Treatments: Drug: cold blood cardioplegia; Drug: del Nido cardioplegia

Study type: Interventional

Funder types: Other

Identifiers

NCT03818126

DELNIDO01

Details and patient eligibility

About

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).

Full 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).

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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")

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

del Nido cardioplegia

Experimental group

Treatment:

Drug: del Nido cardioplegia

cold blood cardioplegia

Active Comparator group

Treatment:

Drug: cold blood cardioplegia