Clinical Impact of Del Nido Cardioplegia in Adult Cardiac Surgery

Heart; Surgery, Heart, Functional Disturbance as Result Clinical Trial

Official title:

Clinical Outcomes of Del Nido Cardioplegia in Adult Cardiac Surgery: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04094168
• Other study ID #: EUDRA CT 2017-005144-14
• Status: Recruiting
• Phase: Phase 4
• Start date: June 15, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: September 2019
• Source: Puerta de Hierro University Hospital
• Contact: Jessica García Suárez
• Phone: +34660164436
• Email: jessicag.suarez[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cardioplegia solutions have been used for myocardial protection in cardiac surgery for decades. Different cardioplegic strategies have been evaluated.

Del Nido cardioplegia was initially used in pediatric patients and has been expanding into adult cardiac centers over the last decade. It can be used as a single dose and it is a reasonable tool do decrease cardioplegic interventions. Recent meta-analysis based on 9 retrospective studies has shown that "clinical outcomes of Del Nido cardioplegia are noninferior to the outcomes of conventional cardioplegia in adult cardiac surgery".

To assess the potencial benefits of Del Nido cardioplegia we performed this clinical trial to evaluate superiority of Del Nido cardioplegia compared to cold blood cardioplegia in terms of myocardial protection and clinical-related outcomes. 474 participants will be randomized either into Del Nido cardioplegia protocol or into the cold blood cardioplegia protocol. Perioperative outcomes will be presented.

Description:

This clinical trial is performed at Puerta de Hierro Hospital in Spain. The protocol has been approved by institutional ethical committee and Spanish Agency of medicines and medical devices (AEMPS).

The aim of the study is to evaluate superiority of Del Nido cardioplegia solution compared to cold blood cardioplegia solution in terms of myocardial protection and clinical-related outcomes.

According to results in recent meta-analysis, the author estimated a total sample size of 474 participants to give 80 % of power at the 5% significant level.

Participants aged 18 years or older undergoing elective cardiac surgery are randomized 1:1 to receive Del Nido cardioplegia solution (study group) and cold blood cardioplegia solution (control group).

Primary outcome will be assessed by biochemical variables of myocardial injury (troponin T level at inmediate post-op, 3-12 hours, 12-24 hours, 24-48 hours post-op); and clinical variables: "Presence of acute myocardial infarction within 72 hours after surgery", "Prolonged low cardiac output", "Prolonged postoperative vasoplegia" within 48 hours after surgery and/or "Ventricular tachyarrythmias" within 24 hours after surgery.

Secondary outcomes include intraoperative variables of myocardial protection (incidence of ventricular fibrillation, inotropic and vasopressor support at the end of surgical intervention, cardiopulmonary bypass time, aortic cross-clamp time) and postoperative clinical outcomes variables (mechanical ventilation time, incidence of delirium, stroke, acute renal failure, atrial fibrillation, length of stay in intensive care unit, length of stay in hospital and In-hospital mortality).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 474
• Est. completion date: February 28, 2020
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients age 18 years or older undergoing adult cardiac surgery.

• Elective surgical procedures requiring cardiopulmonary bypass and myocardial arrest.

Exclusion Criteria:

• Emergency surgery.

• Patients on preoperative inotropic support and/or mechanical circulatory support.

• Patient who refuse to participate in the study.

• Lidocaine allergy.

• Port access mitral valve surgery.

Related Conditions & MeSH terms

• Heart; Surgery, Heart, Functional Disturbance as Result

Intervention

Drug:
• DEL NIDO CARDIOPLEGIA
Del Nido components: Plasmalyte 148 (1000 ml), NaHCO3 8.4% 1M (13 ml), MgSO4 0,5 M (16,5 ml), Mannitol 20% (16,3 ml), KCl 2 M (13 ml), Lidocaine 2% (6,5 ml). Electrolytic composition (l000 ml): Na+ 153 mEq, K+ 31 mEq, Cl - 124 mEq, Mg2+ 19,5 mEq, NaHCO3 13 mEq, Acetate 27 mEq, Sulfate 16,5 mEq, Gluconate 23 mEq.
• COLD BLOOD BASED CARDIOPLEGIA
Cardibraun components: Electrolytic composition (1000 ml): Na+ 185,8 mmol, K+ 24,1 mmol, Cl- 192,8 mmol, Acetate 23 mmol, Fosfate 0,97 mmol, Citrate 6,32 mmol.

Locations

Country	Name	City	State
Spain	Puerta de Hierro Hospital	Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
JESSICA GARCIA SUAREZ

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Ad N, Holmes SD, Massimiano PS, Rongione AJ, Fornaresio LM, Fitzgerald D. The use of del Nido cardioplegia in adult cardiac surgery: A prospective randomized trial. J Thorac Cardiovasc Surg. 2018 Mar;155(3):1011-1018. doi: 10.1016/j.jtcvs.2017.09.146. Epub 2017 Nov 13. — View Citation

Buckberg GD, Athanasuleas CL. Cardioplegia: solutions or strategies? Eur J Cardiothorac Surg. 2016 Nov;50(5):787-791. Epub 2016 Jul 1. — View Citation

Lazar HL. del Nido cardioplegia: Passing fad or here to stay? J Thorac Cardiovasc Surg. 2018 Mar;155(3):1009-1010. doi: 10.1016/j.jtcvs.2017.09.126. Epub 2017 Oct 10. — View Citation

Li Y, Lin H, Zhao Y, Li Z, Liu D, Wu X, Ji B, Gao B. Del Nido Cardioplegia for Myocardial Protection in Adult Cardiac Surgery: A Systematic Review and Meta-Analysis. ASAIO J. 2018 May/Jun;64(3):360-367. doi: 10.1097/MAT.0000000000000652. — View Citation

Tam DY, Fremes SE. Del Nido cardioplegia: A one stop shot for adult cardiac surgery? J Thorac Cardiovasc Surg. 2018 Mar;155(3):1019-1020. doi: 10.1016/j.jtcvs.2017.10.066. Epub 2017 Oct 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood troponin levels.	Biochemical variables of myocardial injury: Blood troponin levels measured at admission in intensive care unit, 12, 24, 48 hours post-op.	Up to 48 hours
Primary	Acute cardiovascular event.	Composite outcome of clinical events "Prolonged low cardiac output", "Prolonged postoperative vasoplegia", "Ventricular tachyarrythmias" and/or "Acute myocardial infarction".; Prolonged low cardiac output. Inotropic pharmacologic support more than 48 hours in intensive care unit and/or mechanical circulatory support.; Prolonged postoperative vasoplegia. Vasopressor support more than 48 hours in intensive care unit.; Ventricular tachyarrythmias. Ventricular fibrillation and hemodynamically unstable ventricular tachycardia within 24 hours after surgery.; Acute myocardial infarction within 72 hours after surgery.	Up to 72 hours
Secondary	Ventricular fibrillation after aortic cross-clamp removal.	Incidence of ventricular fibrillation after aortic cross-clamp removal (Y/N).	Intraoperative.
Secondary	Defibrillation requirement.	Defibrillation requirement after aortic cross-clamp removal (Y/N).	Intraoperative.
Secondary	Cardioplegia delivery.	Cardioplegia delivery (antegrade, retrograde, both).	Intraoperative.
Secondary	Cardiopulmonary bypass time (CBP).	Duration of cardiopulmonary bypass (CBP) (min).	Intraoperative.
Secondary	Aortic cross-clamp time	Duration of aortic cross-clamp time (min).	Intraoperative.
Secondary	Return to cardiopulmonary bypass.	Failure to separate from cardiopulmonary bypass (Y/N).	Intraoperative
Secondary	Intraoperative packed red blood cells transfusion.	Intraoperative packed red blood cells transfusion (U).	Intraoperative
Secondary	Intraoperative maximal blood glucose concentration.	Intraoperative maximal blood glucose concentration (mg/dl).	Intraoperative
Secondary	Postoperative atrial fibrillation.	New-onset atrial fibrillation or hemodynamically unstable atrial fibrillation that requires treatment (Y/N).	Up to 2 weeks.
Secondary	Reoperation.	Reoperation within 24 hours after surgery (Y/N).	Up to 24 hours.
Secondary	Inotropic or vasopressor support in intensive care unit.	Inotropic or vasopressor support in intensive care unit (Y/N).	At admission in intensive care unit, 24, 48 hours.
Secondary	Duration of inotropic support after cardiopulmonary bypass.	Duration of inotropic support after cardiopulmonary bypass (hours).	Up to 2 weeks.
Secondary	Time to extubation.	Mechanical ventilation time (min).	Up to 2 weeks.
Secondary	Acute renal failure.	Incidence of renal failure (Requirement for postoperative renal replacement therapy) (Y/N).	Up to 2 weeks.
Secondary	Ischemic stroke.	Incidence of ischemic stroke (Y/N).	Up to 2 weeks.
Secondary	Delirium.	Incidence of delirium (Y/N).	Up to 2 weeks.
Secondary	Postoperative packed red blood cells transfusion.	Postoperative packed red blood cells transfusion (U)	Up to 1 week.
Secondary	Length of stay in intensive care unit	Length of stay in intensive care unit (days).	through study completion, an average 1 month.
Secondary	Length of stay in hospital	Length of stay in hospital (days).	through study completion, an average 6 months.
Secondary	Postoperative ventricular ejection fraction change.	Postoperative ventricular ejection fraction (LVEF) change (Y/N).	through study completion, an average 6 months.
Secondary	Mortality.	Mortality (Y/N).	through study completion, an average 6 months.