Calcium administration In patients undergoing CardiAc suRgery under cardiopulmonary bypasS (ICARUS trial): Rationale and design of a randomized controlled trial.

Calcium chloride Cardiac surgery Cardiopulmonary bypass Hypocalcemia Inotropic support

Journal

Contemporary clinical trials communications
ISSN: 2451-8654
Titre abrégé: Contemp Clin Trials Commun
Pays: Netherlands
ID NLM: 101671157

Informations de publication

Date de publication:
Sep 2021
Historique:
received: 06 12 2020
revised: 27 07 2021
accepted: 17 08 2021
entrez: 6 9 2021
pubmed: 7 9 2021
medline: 7 9 2021
Statut: epublish

Résumé

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. 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. 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 Ca 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.

Identifiants

pubmed: 34485754
doi: 10.1016/j.conctc.2021.100835
pii: S2451-8654(21)00136-8
pmc: PMC8406154
doi:

Types de publication

Journal Article

Langues

eng

Pagination

100835

Informations de copyright

© 2021 The Authors.

Déclaration de conflit d'intérêts

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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Auteurs

Vladimir Lomivorotov (V)

E. Meshalkin National Medical Research Centre, Novosibirsk, Russian Federation.
Novosibirsk State University, Novosibirsk, Russian Federation.

Dmitry Ponomarev (D)

E. Meshalkin National Medical Research Centre, Novosibirsk, Russian Federation.

Vladimir Boboshko (V)

E. Meshalkin National Medical Research Centre, Novosibirsk, Russian Federation.

Vladimir Shmyrev (V)

E. Meshalkin National Medical Research Centre, Novosibirsk, Russian Federation.

Samandar Ismoilov (S)

E. Meshalkin National Medical Research Centre, Novosibirsk, Russian Federation.

Sergey Efremov (S)

Saint Petersburg State University Hospital, Saint Petersburg, Russian Federation.

Nikolay Kamenshchikov (N)

Сardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russian Federation.

Boris Akselrod (B)

Petrovsky National Research Centre of Surgery, Moscow, Russian Federation.

Vadim Pasyuga (V)

Federal Center for Cardiovascular Surgery, Astrakhan, Russian Federation.

Dmitry Urusov (D)

District Clinical Hospital, Khanty-Mansiysk, Russian Federation.

Alexey Ovezov (A)

Moscow Regional Research and Clinical Institute (MONIKI), Moscow, Russian Federation.

Mikhail Evdokimov (M)

Federal Center for Cardiovascular Surgery, Penza, Russian Federation.

Alexander Turchaninov (A)

Federal Center for Cardiovascular Surgery, Chelyabinsk, Russian Federation.

Alexander Bogachev-Prokofiev (A)

E. Meshalkin National Medical Research Centre, Novosibirsk, Russian Federation.

Nazar Bukamal (N)

Sh. Mohammed Bin Khalifa Bin Sulman Al-Khalifa Cardiac Center, Awali, Bahrain.

Sarah Afifi (S)

King Abdullah Medical City, Makkah, Saudi Arabia.

Alessandro Belletti (A)

IRCCS San Raffaele Scientific Institute, Milan, Italy.

Rinaldo Bellomo (R)

The University of Melbourne, Melbourne, Australia.

Giovanni Landoni (G)

IRCCS San Raffaele Scientific Institute, Milan, Italy.
Vita-Salute San Raffaele University, Milan, Italy.

Classifications MeSH