Calcium administration In patients undergoing CardiAc suRgery under cardiopulmonary bypasS (ICARUS trial): Rationale and design of a randomized controlled trial. / Lomivorotov, Vladimir; Ponomarev, Dmitry; Boboshko, Vladimir et al.
In: Contemporary Clinical Trials Communications, Vol. 23, 100835, 09.2021.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - Calcium administration In patients undergoing CardiAc suRgery under cardiopulmonary bypasS (ICARUS trial): Rationale and design of a randomized controlled trial
AU - Lomivorotov, Vladimir
AU - Ponomarev, Dmitry
AU - Boboshko, Vladimir
AU - Shmyrev, Vladimir
AU - Ismoilov, Samandar
AU - Efremov, Sergey
AU - Kamenshchikov, Nikolay
AU - Akselrod, Boris
AU - Pasyuga, Vadim
AU - Urusov, Dmitry
AU - Ovezov, Alexey
AU - Evdokimov, Mikhail
AU - Turchaninov, Alexander
AU - Bogachev-Prokofiev, Alexander
AU - Bukamal, Nazar
AU - Afifi, Sarah
AU - Belletti, Alessandro
AU - Bellomo, Rinaldo
AU - Landoni, Giovanni
N1 - Publisher Copyright: © 2021 The Authors
PY - 2021/9
Y1 - 2021/9
N2 - 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.
AB - 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.
KW - Calcium chloride
KW - Cardiac surgery
KW - Cardiopulmonary bypass
KW - Hypocalcemia
KW - Inotropic support
UR - http://www.scopus.com/inward/record.url?scp=85122673129&partnerID=8YFLogxK
U2 - 10.1016/j.conctc.2021.100835
DO - 10.1016/j.conctc.2021.100835
M3 - Article
C2 - 34485754
AN - SCOPUS:85122673129
VL - 23
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
SN - 2451-8654
M1 - 100835
ER -
ID: 35259861