Cardiac surgery
Conditions
Interventions
Product Name: del Nido Cardioplegic solution
Pharmaceutical Form: Solution for cardioplegia
INN or Proposed INN: SODIUM BICARBONATE BP
Other descriptive name: SODIUM BICARBONATE BP
Concentration unit:
Sponsors
Dr. Forteza Gil
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients over 18 years of age. • Patients undergoing scheduled surgery under extracorporeal circulation. • Patients who, after receiving information about the study, authorize their participation in writing. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 474 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 474
Exclusion criteria
Exclusion criteria: • Patients under 18 years of age. • Patients who do not consent to participate in the study. • Documented allergy to amide-type local anesthetics. • Emergent surgery. It includes: --- Surgery: cardiac transplant, aortic dissection, endocarditis, shock code. --- Regardless of the type of surgical intervention, all those unstable patients who require pharmacological inotropic support, mechanical support (BCIAO, ECMO) or preoperative intubation. • Patients undergoing surgery scheduled under a minimally invasive Heart Port procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess prospectively the two types of cardioplegia used regularly in our Center.;Secondary Objective: Record and assess the clinical data and complications associated with the treatment.;Timepoint(s) of evaluation of this end point: Interim analysis planned on October 2018 (indicative date). Final analysis planned on June 2019.;Primary end point(s): Acute cardiovascular event (Yes / No). Composite variable formed by one or more of the following events: • Early perioperative infarction (first 72 hours after surgery). Defined according to the criteria of the Working Team of the European Society of Cardiology, the AHA (American Heart Association) and the WHF (World Heart Federation), as the elevation of cardiac biomarkers (troponin T, CK) 10 times the 99th percentile of the normal reference value, together with at least one of the following parameters: --- Appearance of new waves Q. --- Appearance of a new left branch block. --- Angiographic evidence of new occlusion of native vessels or grafts. --- Alterations of contractility detected by ETT or TEE not present before surgery. • Prolonged low cardiac output. Defined as the need to maintain support with two or more inotropic drugs and / or other circulatory mechanical assistance devices (BCIAo, ECMO) at 24 h postoperatively. • Appearance of arrhythmias (TV / FV) requiring CVE in the first 24 hours postoperatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Need for electrical cardioversion (Yes / No). • Number of electrical Cardioversion required. • Use of intraoperative antiarrhythmics drugs. • Postoperative AF appearance (Yes / No). • Requirement of inotropic pharmacological support. Time until the total withdrawal of the inotropic support. • Intraoperative and postoperative blood transfusion. • Acute kidney failure. Defined by KDIGO scale. • Postoperative sepsis (Yes / No). Defined according to current guidelines (SOFA). • Postoperative pneumonia (Yes / No). Defined as the appearance of a pulmonary infiltrate and at least one of the following criteria: fever, leukocytosis, positive respiratory cultures. • Seizure activity (Yes / No): Defined as the appearance of tonic-clonic movements and / or the appearance of epileptiform electrical activity in EEG. • Stroke (ACVA) (Yes / No). Defined as the development of focal or global signs of brain function compromise, with symptoms lasting 24 hours or more, as evidenced by cranial CT or brain MRI. Additional efficacy and safety variables. • Ischemia time (min). • Perfusion time (min). • Volume of administered cardioplegic solution (ml). • Route of administration (Anterograde / retrograde / dual). • Reperfusion solution administration (Yes / No). • Time from the administration of cardioplegia to the electromechanical stop of the heart. • Value of Troponins and CK upon arrival at ICU and at 24 hours of stay. Maximum peak of Troponins and CK in the first 24 hours postoperatively. • Hemoglobin value upon arrival at ICU and at 24 hours of stay. • Mechanical ventilation time from admission in ICU to extubation (min). • Need for renal replacement therapy (CRRT, HD). • Need for re-entry in ICU (Yes / No). • Time of stay in ICU and hospital (Days). • Left ventricular ejection fraction at hospital discharge. • Mortality (Yes / No). Survival at 30 days. • Disaggregated costs of the cardioplegic solution (price / bag). • Costs related to the time of stay in I | — |
Countries
Spain
Contacts
Public ContactDra. Jessica García Suárez
Dra. Jessica García Suárez
Outcome results
None listed