The Del Nido Versus Cold Blood Cardioplegia in Aortic Valve Replacement

Aortic Valve Disease Clinical Trial

Official title:

The Del Nido Cardioplegia Versus the Cold Blood Cardioplegia in Adult Patients Undergoing Aortic Valve Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03818126
• Other study ID #: DELNIDO01
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: July 31, 2018

Study information

• Verified date: January 2019
• Source: American Heart of Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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")

Related Conditions & MeSH terms

• Aortic Valve Disease
• Ischemia
• Ischemia-reperfusion Injury
• Reperfusion Injury

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	1st Department of Cardiac Surgery	Bielsko-Biala

Sponsors (1)

Lead Sponsor	Collaborator
Pawel Buszman

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrical cardiac activity during cross-clamp	Electrical activity observed during the cardiac arrest (cross-clamp)	intraoperative
Primary	Ventricular fibrillation during reperfusion	Ventricular fibrillation as first observed rhythm after removing the aortic cross-clamp	intraoperative
Primary	hs-TnT (High sensitivity troponin T) - 24 hours	High sensitivity troponin T measured 24 hours postoperatively	24 hours postoperatively
Primary	hs-TnT (High sensitivity troponin T) - 48 hours	High sensitivity troponin T measured 48 hours postoperatively	48 hours postoperatively
Primary	CK-MB (Creatine kinase- MB isoenzyme) - 24 hours	Creatine kinase (MB isoenzyme) measured 24 hours postoperatively	24 hours postoperatively
Primary	CK-MB (Creatine kinase- MB isoenzyme) - 48 hours	Creatine kinase (MB isoenzyme) measured 48 hours postoperatively	48 hours postoperatively
Secondary	Ventricular fibrillation during the cardioplegia administration		intraoperative
Secondary	Time from the beginning of cardioplegia administration to cardiac arrest		intraoperative
Secondary	Procedural use of the pacemaker		intraoperative
Secondary	Intraoperative myocardial infarction		intraoperative
Secondary	Fall of ejection fraction (EF)	5% fall in the EF	48 hours
Secondary	Inotrope administration		intraoperative, 48 hours
Secondary	Use of the intraaortic balloon pump		intraoperative, 48 hours
Secondary	Perioperative atrial fibrillation		up to 2 weeks
Secondary	Perioperative arrhythmia (other than AF)		up to 2 weeks
Secondary	Postoperative packed red blood cells transfusion		up to 2 weeks
Secondary	Perioperative creatinine values		up to 2 weeks
Secondary	Kidney injury	The creatinine elevation >25% or >0.5mg/dl	up to 2 weeks
Secondary	CVVHDF	Use of continous veno-venous hemodiafiltration	up to 2 weeks
Secondary	Cardiac death	death from cardiac reasons (e.g. myocardial infarction, low ejection fraction, arrhythmia).	30 days postoperative
Secondary	Overall mortality		30 days postoperative