Termination of cardiopulmonary bypass is a critical step in any cardiac surgical procedure and requires a thorough planning. Debate about rationale of calcium administration during weaning of cardiopulmonary bypass has been conducted for several decades; however, a consensus has not been yet reached. Perioperative hypocalcemia can develop because of haemodilution or calcium binding from heparin, albumin and citrate. Perioperative hypocalcemia is often complicated by development of arrhythmias, especially QT interval prolongation. Furthermore, low content of calcium can lead to vascular tone disorders, violation of neuromuscular transmission, altered hemostasis and heart failure, resistant to inotropic agents, especially in patients with concomitant cardiomyopathy. On the other hand, hypercalcaemia is a dangerous complication in cardiac surgery. Among the fatal, but rather rare complications, there are acute pancreatitis and the phenomenon of the "stone heart", which is essentially a reperfusion injury of the myocardium caused by rapid calcium overload. Hypercalcaemia can also trigger rhythm disturbances, hypertension, increase systemic vascular resistance, reduce diastolic compliance and impair relaxation of the myocardium due to excessive calcium intake into the cardiomyocytes, cause coronary vasospasm and aggravate ischaemic myocardial damage, impair arterial graft blood flow during aortocoronary and mammary coronary bypass surgery. To date, there is a lack of data indicating clinical efficacy of calcium administration before separation from CPB. Therefore, we designed this randomized controlled trial to test the hypothesis whether calcium administration at termination of CPB will reduce the need for inotropic support at the end of surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
820
Calcium Chloride
0.9% Sodium Chloride
Sh. Mohammed Bin Khalifa Bin Salman Al-Khalifa Cardiac Center
Manama, Bahrain
Federal Center for Cardiovascular Surgery
Astrakhan, Russia
Federal Center for Cardiovascular Surgery
Chelyabinsk, Russia
District clinical hospital
Khanty-Mansiysk, Russia
B.V. Petrovsky Russian Scientific Surgery Center
Moscow, Russia
M. Vladimirsky Moscow Regional Research Cinical Institute (MONIKI)
Moscow, Russia
Meshalkin Research Institute of Pathology of Circulation
Novosibirsk, Russia
Federal Center for Cardiovascular Surgery
Penza, Russia
St Petersburg University Multifunctional Clinical Centre
Saint Petersburg, Russia
Tomsk National Research Medical Center
Tomsk, Russia
...and 1 more locations
Inotropic support
Number of patients requiring inotropic and/or vasopressor support started at any dose during the period starting at termination of CPB and ending at completion of surgery
Time frame: Intraoperatively
Duration of inotropic support after surgery
Duration of infusion of any vasoinotropic agent at any dose
Time frame: 30 days after surgery
Vasoactive-inotropic score
Vasoactive-inotropic score will be measured 4 hours after transfer to ICU and on morning of postoperative day 1. The inotropic score will be calculated using the following formula: Dobutamine dose (in mcg/kg/min) + Dopamine dose (in mcg/kg/min) + Enoximone dose (in mcg/kg/min) + \[Epinephrine dose (in mcg/kg/min) x 100\] + \[Norepinephrine dose (in mcg/kg/min) x 100\].
Time frame: Postoperative day 1
Plasma Ca2+ concentration before and after drug administration
Time frame: Intraoperatively
Time spent in theatre after cardiopulmonary bypass
Time frame: Intraoperatively
CPB duration
Duration of cardiopulmonary bypass
Time frame: intraoperatively
Duration of ventilation
Time frame: Up to 30 day after randomization
Duration of intensive care unit stay
Time frame: Up to 30 day after randomization
ICU readmission
Readmission to intensive care unit
Time frame: Postoperatively until hospital discharge
Hospital stay
Duration of hospital stay
Time frame: Postoperatively until hospital discharge
Myocardial infarction
Number of patients who develop myocardial infarction
Time frame: Up to 30 day after randomization
Type 1 and type 2 neurological complications
Number of patients who develop type 1 and type 2 develop myocardial infarction
Time frame: Up to 30 day after randomization
Postoperative blood loss
Postoperative blood (ml/kg) loss will be measured on the morning of postoperative day 1
Time frame: Postoperative day 1
Need for blood transfusion after surgery
Number of patients who will need transfuion of any blood products (red cells, fresh frozen plasma, cryoprecipitate)
Time frame: Up to 30 day after randomization
Myocardial ischaemia on ECG after arrival to ICU
Number of patients who develop myocardial ischemia
Time frame: Postoperative day 1
Concentration of alpha-amylase after surgery
Time frame: Postoperative day 1
Internal mammary artery vascular resistance (if available)
Will be defined by intraoperative graft flow measurements
Time frame: Intraoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.