Clinical trial NCT03818126: The Del Nido Versus Cold Blood Cardioplegia in Aortic Valve Replacement
Official title: The Del Nido Cardioplegia Versus the Cold Blood Cardioplegia in Adult Patients Undergoing Aortic Valve Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Disease
Ischemia-reperfusion Injury
Keywords: del Nido
cardioplegia
aortic valve
Lead sponsor: American Heart of Poland
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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")

Primary outcomes:
measure: Electrical cardiac activity during cross-clamp
timeFrame: intraoperative
measure: Ventricular fibrillation during reperfusion
timeFrame: intraoperative
measure: hs-TnT (High sensitivity troponin T) - 24 hours
timeFrame: 24 hours postoperatively
measure: hs-TnT (High sensitivity troponin T) - 48 hours
timeFrame: 48 hours postoperatively
measure: CK-MB (Creatine kinase- MB isoenzyme) - 24 hours
timeFrame: 24 hours postoperatively
measure: CK-MB (Creatine kinase- MB isoenzyme) - 48 hours
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Ventricular fibrillation during the cardioplegia administration
timeFrame: intraoperative
measure: Time from the beginning of cardioplegia administration to cardiac arrest
timeFrame: intraoperative
measure: Procedural use of the pacemaker
timeFrame: intraoperative
measure: Intraoperative myocardial infarction
timeFrame: intraoperative
measure: Fall of ejection fraction (EF)
timeFrame: 48 hours
measure: Inotrope administration
timeFrame: intraoperative, 48 hours
measure: Use of the intraaortic balloon pump
timeFrame: intraoperative, 48 hours
measure: Perioperative atrial fibrillation
timeFrame: up to 2 weeks
measure: Perioperative arrhythmia (other than AF)
timeFrame: up to 2 weeks
measure: Postoperative packed red blood cells transfusion
timeFrame: up to 2 weeks
measure: Perioperative creatinine values
timeFrame: up to 2 weeks
measure: Kidney injury
timeFrame: up to 2 weeks
measure: CVVHDF
timeFrame: up to 2 weeks
measure: Cardiac death
timeFrame: 30 days postoperative
measure: Overall mortality
timeFrame: 30 days postoperative
Other outcomes:
Locations:
city: Bielsko-Biała
country: Poland
facility: 1st Department of Cardiac Surgery
Study officials:
affiliation: 1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biala, Poland
name: Marek Cisowski, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: