The Del Nido Versus Cold Blood Cardioplegia in Aortic Valve Replacement

NCT03818126 | Completed

• 1 other identifier: DELNIDO01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Aortic Valve Disease; Ischemia-reperfusion Injury

Keywords

del Nido; cardioplegia; aortic valve

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (15)

• 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)

  48 hours

Study Arms (2)

del Nido cardioplegia

EXPERIMENTAL

Drug: del Nido cardioplegia

cold blood cardioplegia

ACTIVE COMPARATOR

Drug: cold blood cardioplegia

Interventions

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.

del Nido cardioplegia

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.

cold blood cardioplegia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• qualification for isolated aortic valve replacement
• age\>18 years
• given consent for the study

You may not qualify if:

• reoperation
• allergy to lidocaine
• coronary artery disease requiring surgical or percutaneous intervention
• pregnancy
• ejection fraction\<30%
• massive aortic calcification ("porcelain aorta")

Sponsors & Collaborators

• Pawel Buszman: lead

Study Sites (1)

1st Department of Cardiac Surgery

Bielsko-Biala, 43-316, Poland

Location

MeSH Terms

Conditions

Aortic Valve Disease; Reperfusion Injury

Interventions

Del Nido cardioplegia solution

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marek Cisowski, MD,PhD

  1st Department of Cardiac Surgery, American Heart of Poland, Bielsko-Biala, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Executive Officer

Study Record Dates

• First Submitted: January 20, 2019
• First Posted: January 28, 2019
• Study Start: July 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: July 31, 2018
• Last Updated: January 28, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)