A Phase 4 interventional study of Calcium Chloride and 0.9% Sodium Chloride in Cardiac Surgery and Cardiopulmonary Bypass, sponsored by Meshalkin Research Institute of Pathology of Circulation. Completed at 11 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Meshalkin Research Institute of Pathology of Circulation · Phase 4, Interventional, and Treatment
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.
Meshalkin Research Institute of Pathology of Circulation is the lead sponsor of 119 studies on the registry; 9 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomly assigned to the experimental group will receive 15 mg/kg of calcium chloride (bolus) intravenously during separation from cardiopulmonary bypass
Drug: Calcium Chloride
Participants randomly assigned to the placebo group will receive equivalent amount of placebo intravenously during separation from cardiopulmonary bypass
Drug: 0.9% Sodium Chloride
Calcium Chloride
0.9% Sodium Chloride
Inotropic support
Need for inotropic and/or vasopressor support using any of the following drugs: epinephrine, norepinephrine, dopamine, dobutamine, vasopressin, phenylephrine started at any dose during surgery after CPB weaning
Time frame: Intraoperatively
Total duration of vasoactive support
Total duration of vasoactive support (starting at the beginning of weaning from CPB) among patients who required inotropes/vasopressors
Time frame: 30 days after surgery
Myocardial ischaemia on ECG after arrival to ICU
Signs of myocardial ischaemia on electrocardiogram after arrival to ICU
Time frame: Postoperative day 1
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
Ionized calcium levels immediately before and 10-15 min after study drug administration
Time frame: Intraoperatively
Myocardial infarction
Number of patients who develop myocardial infarction
Time frame: Up to 30 day after randomization
Postoperative blood loss
Blood loss on the morning of POD 1 (expressed as ml/kg)
Time frame: Postoperative day 1
Need for blood transfusion after surgery
Number of patients who will need for postoperative red blood cells transfusion
Time frame: Up to 30 day after randomization
30-day mortality
All-cause 30-day mortality
Time frame: 30-days after randomization
CPB duration
Duration of cardiopulmonary bypass
Time frame: intraoperatively
Duration of ventilation
Time frame: Up to 30 day after randomization
Time spent in theatre after cardiopulmonary bypass
Time frame: Intraoperatively
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
Type 1 and type 2 neurological complications
Number of patients who develop type 1 and type 2 develop neurological complications according to standard definitions
Time frame: Up to 30 day after randomization
Internal mammary artery vascular resistance (if available)
Will be defined by intraoperative graft flow measurements
Time frame: Intraoperatively
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Calcium Chloride
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