Calcium chloride
DrugCalcium Chloride
NCT Number: NCT03772990
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Sh. Mohammed Bin Khalifa Bin Salman Al-Khalifa Cardiac Center, Manama, Bahrain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Calcium Chloride
0.9% Sodium Chloride
Time frame: Intraoperatively
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: 30 days after surgery
Duration of infusion of any vasoinotropic agent at any dose
Time frame: Postoperative day 1
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: Intraoperatively
Time frame: Intraoperatively
Time frame: intraoperatively
Duration of cardiopulmonary bypass
Time frame: Up to 30 day after randomization
Time frame: Up to 30 day after randomization
Time frame: Postoperatively until hospital discharge
Readmission to intensive care unit
Time frame: Postoperatively until hospital discharge
Duration of hospital stay
Time frame: Up to 30 day after randomization
Number of patients who develop myocardial infarction
Time frame: Up to 30 day after randomization
Number of patients who develop type 1 and type 2 develop myocardial infarction
Time frame: Postoperative day 1
Postoperative blood (ml/kg) loss will be measured on the morning of postoperative day 1
Time frame: Up to 30 day after randomization
Number of patients who will need transfuion of any blood products (red cells, fresh frozen plasma, cryoprecipitate)
Time frame: Postoperative day 1
Number of patients who develop myocardial ischemia
Time frame: Postoperative day 1
Time frame: Intraoperatively
Will be defined by intraoperative graft flow measurements
Meshalkin Research Institute of Pathology of Circulation
Network
Calcium Administration in Patients Undergoing Cardiac Surgery Under Cardiopulmonary Bypass (ICARUS Trial): Prospective Randomized, Double-blind Placebo-controlled Superiority Trial
Acronym: ICARUS
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