Calcium Administration in Cardiac Surgery

Last updated: November 7, 2024
Sponsor: Meshalkin Research Institute of Pathology of Circulation
Overall Status: Active - Recruiting

Phase

4

Condition

Cardiac Surgery

Treatment

0.9% Sodium Chloride

Calcium Chloride

Clinical Study ID

NCT03772990
21/2019
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • surgery under cardiopulmonary bypass

  • valve or valve surgery + CABG

  • age > 18 years

  • signed informed consent

Exclusion

Exclusion Criteria:

  • 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

Total Participants: 818
Treatment Group(s): 2
Primary Treatment: 0.9% Sodium Chloride
Phase: 4
Study Start date:
January 14, 2019
Estimated Completion Date:
August 30, 2025

Connect with a study center

  • Sh. Mohammed Bin Khalifa Bin Salman Al-Khalifa Cardiac Center

    Manama,
    Bahrain

    Active - Recruiting

  • Federal Center for Cardiovascular Surgery

    Astrakhan,
    Russian Federation

    Active - Recruiting

  • Federal Center for Cardiovascular Surgery

    Chelyabinsk,
    Russian Federation

    Active - Recruiting

  • District clinical hospital

    Khanty-Mansiysk,
    Russian Federation

    Active - Recruiting

  • B.V. Petrovsky Russian Scientific Surgery Center

    Moscow,
    Russian Federation

    Active - Recruiting

  • M. Vladimirsky Moscow Regional Research Cinical Institute (MONIKI)

    Moscow,
    Russian Federation

    Active - Recruiting

  • Meshalkin Research Institute of Pathology of Circulation

    Novosibirsk, 630055
    Russian Federation

    Active - Recruiting

  • Federal Center for Cardiovascular Surgery

    Penza,
    Russian Federation

    Active - Recruiting

  • St Petersburg University Multifunctional Clinical Centre

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • Tomsk National Research Medical Center

    Tomsk,
    Russian Federation

    Active - Recruiting

  • King Abdullah Medical City

    Mecca,
    Saudi Arabia

    Active - Recruiting

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