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Completed

NCT Number: NCT03818126

The Del Nido Versus Cold Blood Cardioplegia in 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).

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Key information

Conditions

Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ischemia-Reperfusion Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

1st Department of Cardiac Surgery

Bielsko-Biala, 43-316, Poland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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")

Treatment and study plan

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.

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.

Primary outcomes

  1. Electrical cardiac activity during cross-clamp

    Time frame: intraoperative

    Electrical activity observed during the cardiac arrest (cross-clamp)

  2. Ventricular fibrillation during reperfusion

    Time frame: intraoperative

    Ventricular fibrillation as first observed rhythm after removing the aortic cross-clamp

  3. hs-TnT (High sensitivity troponin T) - 24 hours

    Time frame: 24 hours postoperatively

    High sensitivity troponin T measured 24 hours postoperatively

  4. hs-TnT (High sensitivity troponin T) - 48 hours

    Time frame: 48 hours postoperatively

    High sensitivity troponin T measured 48 hours postoperatively

  5. CK-MB (Creatine kinase- MB isoenzyme) - 24 hours

    Time frame: 24 hours postoperatively

    Creatine kinase (MB isoenzyme) measured 24 hours postoperatively

  6. CK-MB (Creatine kinase- MB isoenzyme) - 48 hours

    Time frame: 48 hours postoperatively

    Creatine kinase (MB isoenzyme) measured 48 hours postoperatively

Secondary outcomes

  1. Ventricular fibrillation during the cardioplegia administration

    Time frame: intraoperative

  2. Time from the beginning of cardioplegia administration to cardiac arrest

    Time frame: intraoperative

  3. Procedural use of the pacemaker

    Time frame: intraoperative

  4. Intraoperative myocardial infarction

    Time frame: intraoperative

  5. Fall of ejection fraction (EF)

    Time frame: 48 hours

    5% fall in the EF

  6. Inotrope administration

    Time frame: intraoperative, 48 hours

  7. Use of the intraaortic balloon pump

    Time frame: intraoperative, 48 hours

  8. Perioperative atrial fibrillation

    Time frame: up to 2 weeks

  9. Perioperative arrhythmia (other than AF)

    Time frame: up to 2 weeks

  10. Postoperative packed red blood cells transfusion

    Time frame: up to 2 weeks

  11. Perioperative creatinine values

    Time frame: up to 2 weeks

  12. Kidney injury

    Time frame: up to 2 weeks

    The creatinine elevation >25% or >0.5mg/dl

  13. CVVHDF

    Time frame: up to 2 weeks

    Use of continous veno-venous hemodiafiltration

  14. Cardiac death

    Time frame: 30 days postoperative

    death from cardiac reasons (e.g. myocardial infarction, low ejection fraction, arrhythmia).

  15. Overall mortality

    Time frame: 30 days postoperative

Sponsors and collaborators

Lead sponsor

Pawel Buszman

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 28, 2019
Registry last updated
Jan 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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