The Del Nido Versus Cold Blood Cardioplegia in Aortic Valve Replacement

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

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).

Study Overview

• Status: Completed
• Conditions: Aortic Valve Disease; Ischemia-reperfusion Injury
• Intervention / Treatment: Drug: del Nido cardioplegia; Drug: cold blood cardioplegia

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).

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Bielsko-Biała, Poland, 43-316
    • 1st Department of Cardiac Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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")

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: del Nido cardioplegia	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.
Active Comparator: cold blood cardioplegia	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventricular fibrillation during the cardioplegia administration		intraoperative
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)	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

Collaborators and Investigators

• Sponsor: Pawel Buszman
• Investigators: Principal Investigator: Marek Cisowski, MD,PhD, 1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biala, Poland

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: January 20, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 28, 2019

Study Record Updates

• Last Update Posted (Actual): January 28, 2019
• Last Update Submitted That Met QC Criteria: January 25, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: aortic valve; del Nido; cardioplegia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Heart Valve Diseases; Ischemia; Reperfusion Injury; Aortic Valve Disease
• Other Study ID Numbers: DELNIDO01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No