Calcium Administration in Cardiac Surgery

NCT03772990 | Completed Phase 4 DMC

• 1 other identifier: 21/2019
• Study Type: interventional
• Target: 818
• Locations: 3 countries
• Sites: 11

Brief 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.

Conditions

Cardiac Surgery; Cardiopulmonary Bypass

Keywords

inotropic support; calcium chloride; cardiopulmonary bypass; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Inotropic support

  Number of patients requiring inotropic support before transfer to intensive care unit

  Intraoperatively

Secondary Outcomes (15)

• Duration of inotropic support after surgery

  30 days after surgery

• Vasoactive-inotropic score

  Postoperative day 1

• Plasma Ca2+ concentration before and after drug administration

  Intraoperatively

• Time spent in theatre after cardiopulmonary bypass

  Intraoperatively

• Duration of ventilation

  Up to 30 day after randomization

Study Arms (2)

Calcium chloride

EXPERIMENTAL

Participants randomly assigned to the experimental group will receive 15 mg/kg of calcium chloride (bolus) intravenously during separation from cardiopulmonary bypass

Drug: Calcium Chloride

0,9% Sodium Chloride

PLACEBO COMPARATOR

Participants randomly assigned to the placebo group will receive equivalent amount of placebo intravenously during separation from cardiopulmonary bypass

Drug: 0.9% Sodium Chloride

Interventions

Calcium Chloride DRUG

Calcium Chloride

Calcium chloride

0.9% Sodium Chloride DRUG

0.9% Sodium Chloride

0,9% Sodium Chloride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead
• Università Vita-Salute San Raffaele: collaborator

Study Sites (11)

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

Manama, Bahrain

Location

Federal Center for Cardiovascular Surgery

Astrakhan, Russia

Location

Federal Center for Cardiovascular Surgery

Chelyabinsk, Russia

Location

District clinical hospital

Khanty-Mansiysk, Russia

Location

B.V. Petrovsky Russian Scientific Surgery Center

Moscow, Russia

Location

M. Vladimirsky Moscow Regional Research Cinical Institute (MONIKI)

Moscow, Russia

Location

Meshalkin Research Institute of Pathology of Circulation

Novosibirsk, 630055, Russia

Location

Federal Center for Cardiovascular Surgery

Penza, Russia

Location

St Petersburg University Multifunctional Clinical Centre

Saint Petersburg, Russia

Location

Tomsk National Research Medical Center

Tomsk, Russia

Location

King Abdullah Medical City

Mecca, Saudi Arabia

Location

MeSH Terms

Interventions

Calcium Chloride; Sodium Chloride

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• Vladimir Lomivorotov

  Meshalkin Research Institute of Pathology of Circulation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 12, 2018
• Study Start: January 14, 2019
• Primary Completion: July 13, 2025
• Study Completion: August 13, 2025
• Last Updated: August 17, 2025

Record last verified: 2024-11

Locations

RU (9); BA (1); SA (1)