Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Aug 18:23:100835.
doi: 10.1016/j.conctc.2021.100835. eCollection 2021 Sep.

Calcium administration In patients undergoing CardiAc suRgery under cardiopulmonary bypasS (ICARUS trial): Rationale and design of a randomized controlled trial

Vladimir Lomivorotov  1   2 , Dmitry Ponomarev  1 , Vladimir Boboshko  1 , Vladimir Shmyrev  1 , Samandar Ismoilov  1 , Sergey Efremov  3 , Nikolay Kamenshchikov  4 , Boris Akselrod  5 , Vadim Pasyuga  6 , Dmitry Urusov  7 , Alexey Ovezov  8 , Mikhail Evdokimov  9 , Alexander Turchaninov  10 , Alexander Bogachev-Prokofiev  1 , Nazar Bukamal  11 , Sarah Afifi  12 , Alessandro Belletti  13 , Rinaldo Bellomo  14 , Giovanni Landoni  13   15
Affiliations

Calcium administration In patients undergoing CardiAc suRgery under cardiopulmonary bypasS (ICARUS trial): Rationale and design of a randomized controlled trial

Vladimir Lomivorotov et al. Contemp Clin Trials Commun. .

Abstract

Introduction: Weaning from cardiopulmonary bypass (CPB) is a critical step of any cardiac surgical procedure and often requires pharmacologic intervention. Calcium ions are pivotal elements for the excitation-contraction coupling process of cardiac myocytes. Thus, calcium administration might be helpful during weaning from CPB.

Methods: We describe a multicenter, placebo-controlled, double blind randomized clinical trial to assess the effect of calcium chloride on the need for inotropic support among adult patients during weaning from CPB. The experimental group (409 patients) will receive 15 mg/kg of calcium chloride. The control group (409 patients) will receive an equivalent volume of 0.9% sodium chloride. Both drugs will be administered intravenously as a bolus at the beginning of weaning from CPB.

Results: The primary outcome will be the need for inotropic support between termination of CPB and completion of surgery. Secondary outcomes will be: duration of inotropic support, vasoactive-inotropic score 30 min after transfer to intensive care unit and on postoperative day 1, plasma alpha-amylase on postoperative day 1, plasma Ca2+ concentration immediately before and 10-15 min after calcium chloride administration, non-fatal myocardial infarction, blood loss on postoperative day 1, need for transfusion of red blood cells, signs of myocardial ischemia on electrocardiogram after arrival to intensive care unit, all-cause mortality at 30 days or during hospital stay if this is longer than 30 days.

Discussion: This trial is designed to assess whether intravenous calcium chloride administration could reduce the need for inotropic support after cardiopulmonary bypass weaning among adults undergoing cardiac surgery.

Keywords: Calcium chloride; Cardiac surgery; Cardiopulmonary bypass; Hypocalcemia; Inotropic support.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Study flow chart. CPB, cardiopulmonary bypass; CABG, coronary artery bypass graft; RCT, randomized controlled trial; RBC, red blood cells.
See this image and copyright information in PMC

References

    1. Kloner R.A., Przyklenk K., Kay G.L. Clinical evidence for stunned myocardium after coronary artery bypass surgery. J. Card. Surg. 1994;9(3 Suppl):397–402. - PubMed
    1. Licker M. Clinical review: management of weaning from cardiopulmonary bypass after cardiac surgery. Ann. Card Anaesth. 2012;15(3):206–223. - PubMed
    1. Belletti A. The effect of inotropes and vasopressors on mortality: a meta-analysis of randomized clinical trials. Br. J. Anaesth. 2015;115(5):656–675. - PubMed
    1. Lomivorotov V.V. Low-cardiac-output syndrome after cardiac surgery. J. Cardiothorac. Vasc. Anesth. 2017;31(1):291–308. - PubMed
    1. Gillies M. Bench-to-bedside review: inotropic drug therapy after adult cardiac surgery -- a systematic literature review. Crit. Care. 2005;9(3):266–279. - PMC - PubMed