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Completed

NCT Number: NCT03772990

Calcium Administration in Cardiac Surgery

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sh. Mohammed Bin Khalifa Bin Salman Al-Khalifa Cardiac Center, Manama, Bahrain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • surgery under cardiopulmonary bypass
  • valve or valve surgery + CABG
  • age > 18 years
  • signed informed consent

Exclusion criteria

  • emergency surgery
  • isolated aortic valve repair/replacement
  • isolated CABG
  • 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

Treatment and study plan

Calcium chloride

Drug

Calcium Chloride

0.9% Sodium Chloride

Drug

0.9% Sodium Chloride

Primary outcomes

  1. Inotropic support

    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

Secondary outcomes

  1. Duration of inotropic support after surgery

    Time frame: 30 days after surgery

    Duration of infusion of any vasoinotropic agent at any dose

  2. Vasoactive-inotropic score

    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].

  3. Plasma Ca2+ concentration before and after drug administration

    Time frame: Intraoperatively

  4. Time spent in theatre after cardiopulmonary bypass

    Time frame: Intraoperatively

  5. CPB duration

    Time frame: intraoperatively

    Duration of cardiopulmonary bypass

  6. Duration of ventilation

    Time frame: Up to 30 day after randomization

  7. Duration of intensive care unit stay

    Time frame: Up to 30 day after randomization

  8. ICU readmission

    Time frame: Postoperatively until hospital discharge

    Readmission to intensive care unit

  9. Hospital stay

    Time frame: Postoperatively until hospital discharge

    Duration of hospital stay

  10. Myocardial infarction

    Time frame: Up to 30 day after randomization

    Number of patients who develop myocardial infarction

  11. Type 1 and type 2 neurological complications

    Time frame: Up to 30 day after randomization

    Number of patients who develop type 1 and type 2 develop myocardial infarction

  12. Postoperative blood loss

    Time frame: Postoperative day 1

    Postoperative blood (ml/kg) loss will be measured on the morning of postoperative day 1

  13. Need for blood transfusion after surgery

    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)

  14. Myocardial ischaemia on ECG after arrival to ICU

    Time frame: Postoperative day 1

    Number of patients who develop myocardial ischemia

  15. Concentration of alpha-amylase after surgery

    Time frame: Postoperative day 1

  16. Internal mammary artery vascular resistance (if available)

    Time frame: Intraoperatively

    Will be defined by intraoperative graft flow measurements

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Collaborators

  • Università Vita-Salute San Raffaele

Registry information

Official study title

Calcium Administration in Patients Undergoing Cardiac Surgery Under Cardiopulmonary Bypass (ICARUS Trial): Prospective Randomized, Double-blind Placebo-controlled Superiority Trial

Acronym: ICARUS

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2018
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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