Cardiac SurgeryPhase 4ICARUSNCT03772990
Calcium Administration in Cardiac Surgery
A Phase 4 study testing Calcium Chloride and 0.9% Sodium Chloride in people with Cardiac Surgery and Cardiopulmonary Bypass, run by Meshalkin Research Institute of Pathology of Circulation at 11 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Cardiopulmonary Bypass
- What is being tested?
- Calcium Chloride and 0.9% Sodium Chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 820 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 14 Jan 2019to 8 Sep 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- surgery under cardiopulmonary bypass
- valve or valve surgery + CABG
- age > 18 years
- signed informed consent
Who cannot join
- emergency surgery
- isolated aortic valve repair/replacement
- isolated CABG
- planned (before surgery) blood transfusion
- redo surgery
- known allergy to the study drug
Show all 11Show fewer
- 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
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Russia9 sites
Federal Center for Cardiovascular Surgery
Astrakhan
Federal Center for Cardiovascular Surgery
Chelyabinsk
District clinical hospital
Khanty-Mansiysk
B.V. Petrovsky Russian Scientific Surgery Center
Moscow
M. Vladimirsky Moscow Regional Research Cinical Institute (MONIKI)
Moscow
Meshalkin Research Institute of Pathology of Circulation
Novosibirsk, 630055
Federal Center for Cardiovascular Surgery
Penza
St Petersburg University Multifunctional Clinical Centre
Saint Petersburg
Tomsk National Research Medical Center
Tomsk
Bahrain1 site
Sh. Mohammed Bin Khalifa Bin Salman Al-Khalifa Cardiac Center
Manama
About this study
Official title: Calcium Administration in Patients Undergoing Cardiac Surgery Under Cardiopulmonary Bypass (ICARUS Trial): Prospective Randomized, Double-blind Placebo-controlled Superiority Trial
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.
Read more
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.
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass
- Being tested
- Calcium Chloride, 0.9% Sodium Chloride
- Keywords
- inotropic support, calcium chloride, cardiopulmonary bypass, cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium ChlorideDrug
Calcium Chloride
0.9% Sodium ChlorideDrug
0.9% Sodium Chloride
| Study group | Role | What they receive |
|---|---|---|
| Calcium chloride | Experimental | Participants randomly assigned to the experimental group will receive 15 mg/kg of calcium chloride (bolus) intravenously during separation from cardiopulmonary bypass Receives: Drug: Calcium Chloride |
| 0,9% Sodium Chloride | Placebo comparator | Participants randomly assigned to the placebo group will receive equivalent amount of placebo intravenously during separation from cardiopulmonary bypass Receives: Drug: 0.9% Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Intraoperatively
Secondary outcomes (16)
Total duration of vasoactive support
Total duration of vasoactive support (starting at the beginning of weaning from CPB) among patients who required inotropes/vasopressors
Measured: 30 days after surgery
Myocardial ischaemia on ECG after arrival to ICU
Signs of myocardial ischaemia on electrocardiogram after arrival to ICU
Measured: 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].
Measured: Postoperative day 1
Plasma Ca2+ concentration before and after drug administration
Ionized calcium levels immediately before and 10-15 min after study drug administration
Measured: Intraoperatively
Myocardial infarction
Number of patients who develop myocardial infarction
Measured: Up to 30 day after randomization
Postoperative blood loss
Blood loss on the morning of POD 1 (expressed as ml/kg)
Measured: 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)
Measured: Up to 30 day after randomization
30-day mortality
All-cause 30-day mortality
Measured: 30-days after randomization
CPB duration
Duration of cardiopulmonary bypass
Measured: intraoperatively
Duration of ventilation
Measured: Up to 30 day after randomization
Time spent in theatre after cardiopulmonary bypass
Measured: Intraoperatively
Duration of intensive care unit stay
Measured: Up to 30 day after randomization
ICU readmission
Readmission to intensive care unit
Measured: Postoperatively until hospital discharge
Hospital stay
Duration of hospital stay
Measured: Postoperatively until hospital discharge
Type 1 and type 2 neurological complications
Number of patients who develop type 1 and type 2 develop myocardial infarction
Measured: Up to 30 day after randomization
Internal mammary artery vascular resistance (if available)
Will be defined by intraoperative graft flow measurements
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start14 Jan 2019
- Primary completion13 Jul 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 820 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Collaborators
- Università Vita-Salute San Raffaele
- Responsible party
- Sponsor
- Investigators
- Vladimir Lomivorotov, Principal investigator, Meshalkin Research Institute of Pathology of Circulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772990
- Sponsor's protocol ID
- 21/2019
- Acronym
- ICARUS
- Status last verified
- Nov 2024
- First submitted
- 7 Dec 2018
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Administration in Patients Undergoing Cardiac Surgery Under Cardiopulmonary Bypass (ICARUS Trial): Prospective Randomized, Double-blind Placebo-controlled Superiority Trial
- ClinicalTrials.gov ID
- NCT03772990
- Acronym / sponsor ID
- ICARUS / 21/2019
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass
- Keywords
- inotropic support, calcium chloride, cardiopulmonary bypass, cardiac surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 820 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Collaborators
- Università Vita-Salute San Raffaele
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 13 Jul 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 12 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium chloride | Experimental | Drug: Calcium ChlorideParticipants randomly assigned to the experimental group will receive 15 mg/kg of calcium chloride (bolus) intravenously during separation from cardiopulmonary bypass |
| 0,9% Sodium Chloride | Placebo comparator | Drug: 0.9% Sodium ChlorideParticipants randomly assigned to the placebo group will receive equivalent amount of placebo intravenously during separation from cardiopulmonary bypass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- surgery under cardiopulmonary bypass
- valve or valve surgery + CABG
- age > 18 years
- signed informed consent
Key exclusion criteria (11 listed)
- emergency surgery
- isolated aortic valve repair/replacement
- isolated CABG
- planned (before surgery) blood transfusion
- redo surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium ChlorideCalcium Chloride | Drug | Calcium chloride |
| 0.9% Sodium Chloride0.9% Sodium Chloride | Drug | 0,9% Sodium Chloride |
Primary outcome
Inotropic support
Time frame: Intraoperatively
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
16 secondary outcomes
Total duration of vasoactive support
Time frame: 30 days after surgery
Myocardial ischaemia on ECG after arrival to ICU
Time frame: Postoperative day 1
Vasoactive-inotropic score
Time frame: Postoperative day 1
Plasma Ca2+ concentration before and after drug administration
Time frame: Intraoperatively
Myocardial infarction
Time frame: Up to 30 day after randomization
Postoperative blood loss
Time frame: Postoperative day 1
Need for blood transfusion after surgery
Time frame: Up to 30 day after randomization
30-day mortality
Time frame: 30-days after randomization
CPB duration
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
Time frame: Postoperatively until hospital discharge
Hospital stay
Time frame: Postoperatively until hospital discharge
Type 1 and type 2 neurological complications
Time frame: Up to 30 day after randomization
Internal mammary artery vascular resistance (if available)
Time frame: Intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiac Surgery
Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Aortic Regurgitation, Aortic Valve Insufficiency
RecruitingPhase 4
Acetaminophen-Mannitol Injection and Postoperative Delirium
Postoperative Delirium
Not yet recruiting
Randomized Evaluation of Operating Room Extubation After Cardiac Surgery
Cardiac Surgery
Not yet recruitingObservational study
Biomarkers of Postoperative Complications After Cardiac Surgery
Postoperative Complications
Active, not recruitingPhase 2/3
Equivalence of Oral Melatonin and Oral Midazolam in Preoperative Anxiolysis for Pediatric Fast-Track Cardiac Surgery
Comparative Effectiveness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Lomivorotov principal investigator
Meshalkin Research Institute of Pathology of Circulation
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcium Chloride and 0.9% Sodium Chloride in people with Cardiac Surgery and Cardiopulmonary Bypass, run by Meshalkin Research Institute of Pathology of Circulation at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Russia, Bahrain, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inotropic support (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.