Aortic Valve Disease, Ischemia-reperfusion Injury
Conditions
Keywords
del Nido, cardioplegia, aortic valve
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).
Interventions
The del Nido components are: Plasma-Lyte A (1000ml), Mannitol 20% (16.3ml), MgSO4 50% (4ml) , NaHCO3 8.4% (13ml) , KCl 2mEq/mL (13ml), Lidocaine 1% (13ml). This solution is mixed with autologous patient blood from the cardiopulmonary circuit in a 4:1 ratio (crystalloid:blood). The dosage is 20ml/kg. The target administration pressure is 100-200mmHg and the target administration flow is 200-300ml/min. The solution temperature is 4 degrees Celsius. Additional dose of the cardioplegia is given only if the cross-clamp time exceeds 90 minutes. Due to high volume given in a single delivery, 40 milligrams of furosemide are injected into cardiopulmonary circuit.
The cold blood cardioplegia components are: Plasma-Lyte A (435ml), Mannitol 15% (20ml), NaHCO3 8.4% (20ml), KCl 2mEq/mL (25ml). The solution is mixed with autologous patient blood from the cardiopulmonary circuit in a 1:4 ratio (crystalloid:blood). The initial dose is 15ml/kg and a dose of 5ml/kg is added every 20-30 minutes or whenever cardiac activity is observed. The target administration pressure is 100-200mmHg and the target administration flow is 200-300ml/min. The solution temperature is 4 degrees Celsius.
Sponsors
Pawel Buszman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Electrical cardiac activity during cross-clamp | intraoperative | Electrical activity observed during the cardiac arrest (cross-clamp) |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Ventricular fibrillation during the cardioplegia administration | intraoperative | — |
| 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). |
| Overall mortality | 30 days postoperative | — |
| Perioperative creatinine values | up to 2 weeks | — |
| 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 | — |
Countries
Poland
Outcome results
None listed