Calcium administration during cardiac surgery
Calcium Administration in Patients Undergoing Cardiac Surgery Under Cardiopulmonary Bypass (ICARUS Trial): Prospective Randomized, Double-blind Placebo-controlled Superiority Trial
This study tests if giving calcium during heart surgery helps patients avoid low calcium levels and related problems compared to those who only get a saline solution.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 818 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Meshalkin Research Institute of Pathology of Circulation Research network |
| Locations | 11 sites (Manama and 10 other locations) |
| Trial ID | NCT03772990 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of calcium chloride administration during the weaning phase of cardiopulmonary bypass in cardiac surgery. It aims to address the ongoing debate regarding the necessity and safety of calcium supplementation in preventing perioperative hypocalcemia and its associated complications, such as arrhythmias and vascular tone disorders. The study will involve patients undergoing valve surgery combined with coronary artery bypass grafting (CABG) and will compare outcomes between those receiving calcium chloride and those receiving a saline solution.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old undergoing cardiac surgery involving cardiopulmonary bypass, specifically valve surgery combined with CABG.
Not a fit: Patients who may not benefit from this study include those undergoing emergency surgery, isolated aortic valve procedures, or those with certain medical conditions such as liver cirrhosis or parathyroid disorders.
Why it matters
Potential benefit: If successful, this study could improve patient outcomes by reducing complications associated with calcium imbalances during cardiac surgery.
How similar studies have performed: While there has been ongoing debate regarding calcium administration in cardiac surgery, this specific approach has not been extensively tested in prior studies, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Manama and 10 other locations
- Sh. Mohammed Bin Khalifa Bin Salman Al-Khalifa Cardiac Center — Manama, Bahrain (Recruiting)
- Federal Center for Cardiovascular Surgery — Astrakhan, Russian Federation (Recruiting)
- Federal Center for Cardiovascular Surgery — Chelyabinsk, Russian Federation (Recruiting)
- District clinical hospital — Khanty-Mansiysk, Russian Federation (Recruiting)
- B.V. Petrovsky Russian Scientific Surgery Center — Moscow, Russian Federation (Recruiting)
- M. Vladimirsky Moscow Regional Research Cinical Institute (MONIKI) — Moscow, Russian Federation (Recruiting)
- Meshalkin Research Institute of Pathology of Circulation — Novosibirsk, Russian Federation (Recruiting)
- Federal Center for Cardiovascular Surgery — Penza, Russian Federation (Recruiting)
- St Petersburg University Multifunctional Clinical Centre — Saint Petersburg, Russian Federation (Recruiting)
- Tomsk National Research Medical Center — Tomsk, Russian Federation (Recruiting)
- King Abdullah Medical City — Mecca, Saudi Arabia (Recruiting)
Study contacts
- Principal investigator: Vladimir Lomivorotov — Meshalkin Research Institute of Pathology of Circulation
- Study coordinator: Vladimir Lomivorotov, MD, PhD
- Email: vvlom@mail.ru
- Phone: 83833476058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.