The Del Nido Versus Cold Blood Cardioplegia in Aortic Valve Replacement

NACompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

July 1, 2016

Primary Completion Date

June 30, 2018

Study Completion Date

July 31, 2018

Conditions
Aortic Valve DiseaseIschemia-reperfusion Injury
Interventions
DRUG

del Nido cardioplegia

"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."

DRUG

cold blood cardioplegia

"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."

Trial Locations (1)

43-316

1st Department of Cardiac Surgery, Bielsko-Biala

All Listed Sponsors
lead

Pawel Buszman

OTHER

NCT03818126 - The Del Nido Versus Cold Blood Cardioplegia in Aortic Valve Replacement | Biotech Hunter | Biotech Hunter