Calcium Administration in Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

818 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-14

Study Completion Date

2025-08-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Surgery Cardiopulmonary Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Calcium chloride

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

Group Type EXPERIMENTAL

Calcium Chloride

Intervention Type DRUG

Calcium Chloride

0,9% Sodium Chloride

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

Group Type PLACEBO_COMPARATOR

0.9% Sodium Chloride

Intervention Type DRUG

0.9% Sodium Chloride

Interventions

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Calcium Chloride

Intervention Type DRUG

0.9% Sodium Chloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No