Cardiac Surgery, Cardiopulmonary Bypass
Conditions
Keywords
inotropic support, calcium chloride, cardiopulmonary bypass, cardiac surgery
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.
Interventions
DRUGCalcium Chloride
Calcium Chloride
DRUG0.9% Sodium Chloride
0.9% Sodium Chloride
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Università Vita-Salute San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * isolated CABG * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inotropic support | Intraoperatively | Need for inotropic and/or vasopressor support using any of the following drugs: epinephrine, norepinephrine, dopamine, dobutamine, vasopressin, phenylephrine started at any dose during surgery after CPB weaning |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total duration of vasoactive support | 30 days after surgery | Total duration of vasoactive support (starting at the beginning of weaning from CPB) among patients who required inotropes/vasopressors |
| Myocardial ischaemia on ECG after arrival to ICU | Postoperative day 1 | Signs of myocardial ischaemia on electrocardiogram after arrival to ICU |
| Vasoactive-inotropic score | Postoperative day 1 | Vasoactive-inotropic score will be measured 4 hours after transfer to ICU and on morning of postoperative day 1. The inotropic score will be calculated using the following formula: Dobutamine dose (in mcg/kg/min) + Dopamine dose (in mcg/kg/min) + Enoximone dose (in mcg/kg/min) + \[Epinephrine dose (in mcg/kg/min) x 100\] + \[Norepinephrine dose (in mcg/kg/min) x 100\]. |
| Plasma Ca2+ concentration before and after drug administration | Intraoperatively | Ionized calcium levels immediately before and 10-15 min after study drug administration |
| Myocardial infarction | Up to 30 day after randomization | Number of patients who develop myocardial infarction |
| Postoperative blood loss | Postoperative day 1 | Blood loss on the morning of POD 1 (expressed as ml/kg) |
| Need for blood transfusion after surgery | Up to 30 day after randomization | Number of patients who will need transfuion of any blood products (red cells, fresh frozen plasma, cryoprecipitate) |
| 30-day mortality | 30-days after randomization | All-cause 30-day mortality |
| CPB duration | intraoperatively | Duration of cardiopulmonary bypass |
| Duration of ventilation | Up to 30 day after randomization | — |
| Time spent in theatre after cardiopulmonary bypass | Intraoperatively | — |
| Duration of intensive care unit stay | Up to 30 day after randomization | — |
| ICU readmission | Postoperatively until hospital discharge | Readmission to intensive care unit |
| Hospital stay | Postoperatively until hospital discharge | Duration of hospital stay |
| Type 1 and type 2 neurological complications | Up to 30 day after randomization | Number of patients who develop type 1 and type 2 develop myocardial infarction |
| Internal mammary artery vascular resistance (if available) | Intraoperatively | Will be defined by intraoperative graft flow measurements |
Countries
Bahrain, Russia, Saudi Arabia
Contacts
PRINCIPAL_INVESTIGATORVladimir Lomivorotov
Meshalkin Research Institute of Pathology of Circulation
Outcome results
None listed