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Calcium administration In patients undergoing CardiAc suRgery under cardiopulmonary bypasS (ICARUS trial): Rationale and design of a randomized controlled trial.
Lomivorotov, Vladimir; Ponomarev, Dmitry; Boboshko, Vladimir; Shmyrev, Vladimir; Ismoilov, Samandar; Efremov, Sergey; Kamenshchikov, Nikolay; Akselrod, Boris; Pasyuga, Vadim; Urusov, Dmitry; Ovezov, Alexey; Evdokimov, Mikhail; Turchaninov, Alexander; Bogachev-Prokofiev, Alexander; Bukamal, Nazar; Afifi, Sarah; Belletti, Alessandro; Bellomo, Rinaldo; Landoni, Giovanni.
Afiliação
  • Lomivorotov V; E. Meshalkin National Medical Research Centre, Novosibirsk, Russian Federation.
  • Ponomarev D; Novosibirsk State University, Novosibirsk, Russian Federation.
  • Boboshko V; E. Meshalkin National Medical Research Centre, Novosibirsk, Russian Federation.
  • Shmyrev V; E. Meshalkin National Medical Research Centre, Novosibirsk, Russian Federation.
  • Ismoilov S; E. Meshalkin National Medical Research Centre, Novosibirsk, Russian Federation.
  • Efremov S; E. Meshalkin National Medical Research Centre, Novosibirsk, Russian Federation.
  • Kamenshchikov N; Saint Petersburg State University Hospital, Saint Petersburg, Russian Federation.
  • Akselrod B; Сardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russian Federation.
  • Pasyuga V; Petrovsky National Research Centre of Surgery, Moscow, Russian Federation.
  • Urusov D; Federal Center for Cardiovascular Surgery, Astrakhan, Russian Federation.
  • Ovezov A; District Clinical Hospital, Khanty-Mansiysk, Russian Federation.
  • Evdokimov M; Moscow Regional Research and Clinical Institute (MONIKI), Moscow, Russian Federation.
  • Turchaninov A; Federal Center for Cardiovascular Surgery, Penza, Russian Federation.
  • Bogachev-Prokofiev A; Federal Center for Cardiovascular Surgery, Chelyabinsk, Russian Federation.
  • Bukamal N; E. Meshalkin National Medical Research Centre, Novosibirsk, Russian Federation.
  • Afifi S; Sh. Mohammed Bin Khalifa Bin Sulman Al-Khalifa Cardiac Center, Awali, Bahrain.
  • Belletti A; King Abdullah Medical City, Makkah, Saudi Arabia.
  • Bellomo R; IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Landoni G; The University of Melbourne, Melbourne, Australia.
Contemp Clin Trials Commun ; 23: 100835, 2021 Sep.
Article em En | MEDLINE | ID: mdl-34485754
ABSTRACT

INTRODUCTION:

Weaning from cardiopulmonary bypass (CPB) is a critical step of any cardiac surgical procedure and often requires pharmacologic intervention. Calcium ions are pivotal elements for the excitation-contraction coupling process of cardiac myocytes. Thus, calcium administration might be helpful during weaning from CPB.

METHODS:

We describe a multicenter, placebo-controlled, double blind randomized clinical trial to assess the effect of calcium chloride on the need for inotropic support among adult patients during weaning from CPB. The experimental group (409 patients) will receive 15 mg/kg of calcium chloride. The control group (409 patients) will receive an equivalent volume of 0.9% sodium chloride. Both drugs will be administered intravenously as a bolus at the beginning of weaning from CPB.

RESULTS:

The primary outcome will be the need for inotropic support between termination of CPB and completion of surgery. Secondary outcomes will be duration of inotropic support, vasoactive-inotropic score 30 min after transfer to intensive care unit and on postoperative day 1, plasma alpha-amylase on postoperative day 1, plasma Ca2+ concentration immediately before and 10-15 min after calcium chloride administration, non-fatal myocardial infarction, blood loss on postoperative day 1, need for transfusion of red blood cells, signs of myocardial ischemia on electrocardiogram after arrival to intensive care unit, all-cause mortality at 30 days or during hospital stay if this is longer than 30 days.

DISCUSSION:

This trial is designed to assess whether intravenous calcium chloride administration could reduce the need for inotropic support after cardiopulmonary bypass weaning among adults undergoing cardiac surgery.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials Idioma: En Revista: Contemp Clin Trials Commun Ano de publicação: 2021 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Clinical_trials Idioma: En Revista: Contemp Clin Trials Commun Ano de publicação: 2021 Tipo de documento: Article