drugset / Trial / NCT04094168

Clinical Impact of Del Nido Cardioplegia in Adult Cardiac Surgery

NCT04094168 ↗

Phase 4 Completed 474 enrolled JESSICA GARCIA SUAREZ
RandomizedParallel-groupDouble-blindTreatment

Summary

Cardioplegia solutions have been used for myocardial protection in cardiac surgery for decades. Different cardioplegic strategies have been evaluated. Del Nido cardioplegia was initially used in pediatric patients and has been expanding into adult cardiac centers over the last decade. It can be used as a single dose and it is a reasonable tool do decrease cardioplegic interventions. Recent meta-analysis based on 9 retrospective studies has shown that "clinical outcomes of Del Nido cardioplegia are noninferior to the outcomes of conventional cardioplegia in adult cardiac surgery". To assess the potencial benefits of Del Nido cardioplegia we performed this clinical trial to evaluate superiority of Del Nido cardioplegia compared to cold blood cardioplegia in terms of myocardial protection and clinical-related outcomes. 474 participants will be randomized either into Del Nido cardioplegia protocol or into the cold blood cardioplegia protocol. Perioperative outcomes will be presented.

Timeline

Start
2018-06-15
Primary completion
2019-12-15
Completion
2020-02-28

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator COLD BLOOD BASED CARDIOPLEGIA Unknown — —
Subject Del Nido cardioplegia Unknown 1000 ml —

Indications

No indication recorded.