Calcium Administration in Cardiac Surgery
- Conditions
- Cardiopulmonary BypassCardiac Surgery
- Interventions
- Registration Number
- NCT03772990
- Lead Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 818
- surgery under cardiopulmonary bypass
- valve or valve surgery + CABG
- age > 18 years
- signed informed consent
- emergency surgery
- isolated aortic valve repair/replacement
- planned (before surgery) blood transfusion
- redo surgery
- known allergy to the study drug
- pregnancy
- current enrollment into another RCT (in the last 30 days)
- previous enrollment and randomization to ICARUS trial
- liver cirrhosis (Child B or C)
- transfusion during CPB
- hypo- or hyperparathyreosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0,9% Sodium Chloride 0.9% Sodium Chloride Participants randomly assigned to the placebo group will receive equivalent amount of placebo intravenously during separation from cardiopulmonary bypass Calcium chloride Calcium Chloride Participants randomly assigned to the experimental group will receive 15 mg/kg of calcium chloride (bolus) intravenously during separation from cardiopulmonary bypass
- Primary Outcome Measures
Name Time Method Inotropic support Intraoperatively Number of patients requiring inotropic support before transfer to intensive care unit
- Secondary Outcome Measures
Name Time Method Plasma Ca2+ concentration before and after drug administration Intraoperatively Vasoactive-inotropic score Postoperative day 1 Vasoactive-inotropic score will be measured on the 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 spent in theatre after cardiopulmonary bypass Intraoperatively Need for blood transfusion after surgery Up to 30 day after randomization Number of patients who will need transfuion of any blood products (red cells, fresh frozen plasma, cryoprecipitate)
Intraoperative myocardial ischemia Intraoperatively The presence of intraoperative myocardial ischemia will be defined during continuous intraoperative ECG monitoring after calcium chloride or placebo administration
Internal mammary artery vascular resistance (if available) Intraoperatively Will be defined by intraoperative graft flow measurements
Myocardial infarction Up to 30 day after randomization Number of patients who develop myocardial infarction
Type 1 and type 2 neurological complications Up to 30 day after randomization Number of patients who develop type 1 and type 2 develop myocardial infarction
Postoperative blood loss Postoperative day 1 Postoperative blood (ml/kg) loss will be measured on the morning of postoperative day 1
Myocardial ischaemia on ECG after arrival to ICU Postoperative day 1 Number of patients who develop myocardial ischemia
Atrial fibrillation Up to 30 day after randomization Number of patients who develop postoperative atrial fibrillation
Concentration of alpha-amylase after surgery Postoperative day 1 Duration of inotropic support after surgery 30 days after surgery Duration of infusion of any vasoinotropic agent at any dose
Duration of ventilation Up to 30 day after randomization Duration of intensive care unit stay Up to 30 day after randomization
Trial Locations
- Locations (9)
Federal Center for Cardiovascular Surgery
🇷🇺Penza, Russian Federation
District clinical hospital
🇷🇺Khanty-Mansiysk, Russian Federation
Tomsk National Research Medical Center
🇷🇺Tomsk, Russian Federation
King Abdullah Medical City
🇸🇦Mecca, Saudi Arabia
M. Vladimirsky Moscow Regional Research Cinical Institute (MONIKI)
🇷🇺Moscow, Russian Federation
Meshalkin Research Institute of Pathology of Circulation
🇷🇺Novosibirsk, Russian Federation
Sh. Mohammed Bin Khalifa Bin Salman Al-Khalifa Cardiac Center
🇧🇭Manama, Bahrain
B.V. Petrovsky Russian Scientific Surgery Center
🇷🇺Moscow, Russian Federation
St Petersburg University Multifunctional Clinical Centre
🇷🇺Saint Petersburg, Russian Federation