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COMPLETED
NCT03772990
PHASE4

Calcium Administration in Cardiac Surgery

Sponsor: Meshalkin Research Institute of Pathology of Circulation

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

820

Start Date

2019-01-14

Completion Date

2025-08-08

Last Updated

2026-08-04

Healthy Volunteers

No

Interventions

DRUG

Calcium Chloride

Calcium Chloride

DRUG

0.9% Sodium Chloride

0.9% Sodium Chloride

Locations (11)

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

Manama, Bahrain

Federal Center for Cardiovascular Surgery

Astrakhan, Russia

Federal Center for Cardiovascular Surgery

Chelyabinsk, Russia

District clinical hospital

Khanty-Mansiysk, Russia

B.V. Petrovsky Russian Scientific Surgery Center

Moscow, Russia

M. Vladimirsky Moscow Regional Research Cinical Institute (MONIKI)

Moscow, Russia

Meshalkin Research Institute of Pathology of Circulation

Novosibirsk, Russia

Federal Center for Cardiovascular Surgery

Penza, Russia

St Petersburg University Multifunctional Clinical Centre

Saint Petersburg, Russia

Tomsk National Research Medical Center

Tomsk, Russia

King Abdullah Medical City

Mecca, Saudi Arabia