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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| del Nido cardioplegia | Experimental |
| |
| cold blood cardioplegia | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| del Nido cardioplegia | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Electrical cardiac activity during cross-clamp | Electrical activity observed during the cardiac arrest (cross-clamp) | intraoperative |
| Ventricular fibrillation during reperfusion | Ventricular fibrillation as first observed rhythm after removing the aortic cross-clamp | intraoperative |
| hs-TnT (High sensitivity troponin T) - 24 hours | High sensitivity troponin T measured 24 hours postoperatively | 24 hours postoperatively |
| hs-TnT (High sensitivity troponin T) - 48 hours | High sensitivity troponin T measured 48 hours postoperatively | 48 hours postoperatively |
| CK-MB (Creatine kinase- MB isoenzyme) - 24 hours | Creatine kinase (MB isoenzyme) measured 24 hours postoperatively | 24 hours postoperatively |
| CK-MB (Creatine kinase- MB isoenzyme) - 48 hours | Creatine kinase (MB isoenzyme) measured 48 hours postoperatively | 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Ventricular fibrillation during the cardioplegia administration | intraoperative | |
| Time from the beginning of cardioplegia administration to cardiac arrest | intraoperative | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marek Cisowski, MD,PhD | 1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biala, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1st Department of Cardiac Surgery | Bielsko-Biala | 43-316 | Poland |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C000712134 | Del Nido cardioplegia solution |
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|
| cold blood cardioplegia | Drug | 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. |
|
| Procedural use of the pacemaker |
| intraoperative |
| Intraoperative myocardial infarction | intraoperative |
| Fall of ejection fraction (EF) | 5% fall in the EF | 48 hours |
| 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 |
| Perioperative creatinine values | up to 2 weeks |
| Kidney injury | The creatinine elevation >25% or >0.5mg/dl | up to 2 weeks |
| CVVHDF | Use of continous veno-venous hemodiafiltration | up to 2 weeks |
| Cardiac death | death from cardiac reasons (e.g. myocardial infarction, low ejection fraction, arrhythmia). | 30 days postoperative |
| Overall mortality | 30 days postoperative |
| D011183 |
| Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |