Circulation Reports
Online ISSN : 2434-0790
Protocol Papers
Prevention of Contrast-Induced Nephropathy After Emergency Percutaneous Coronary Intervention With a Single Bolus Administration of High-Concentrate Sodium Bicarbonate　― Rationale and Design of a Single-Arm Study Compared With Historical Controls ―
Takuya Nakamura, Makoto Watanabe , Kazutaka Nogi, Takaaki Kosugi, Yukihiro Hashimoto, Tomoya Ueda, Naofumi Doi, Hiroyuki Kawata, Manabu Horii, Kenichi Ishigami, Tamio Nakajima, Hiroaki Watabe, Daisuke Abe, Koichiro Kuwahara, Yasuo Okumura, Naoki Ozu, Shota Suzuki, Shu Kasama, Yoshihiko Saito
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Keywords: Acute myocardial infarction, Contrast-induced nephropathy, Emergency percutaneous coronary intervention, Sodium bicarbonate
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2023 Volume 5 Issue 4 Pages 152-156

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Abstract

Background: Contrast-induced nephropathy (CIN) is clinically important because of its poor prognosis. The incidence of CIN is higher in emergency than elective percutaneous coronary intervention (PCI) because there is no established method to prevent CIN. The aim of this study is to evaluate whether bolus administration of a concentrated solution of sodium bicarbonate can prevent CIN in patients undergoing emergency PCI.

Methods and Results: This multicenter prospective single-arm trial with historical controls will include patients who are aged ≥20 years and will undergo cardiac catheterization for suspected acute myocardial infarction (AMI). Patients will receive an intravenous bolus administration of concentrated sodium bicarbonate solution (7% or 8.4%, 20 mEq) and will be observed for 72±12 h. Data for the control group, comprising all patients who underwent PCI for AMI between January 1, 2020 and December 31, 2020 across participating hospitals, will be extracted. The primary endpoint is the incidence of CIN, defined as an increase in serum creatinine of >0.5 mg/dL or >25% from baseline within 48±12 h. We will evaluate the endpoints in the prospective group and compare them with those in the historical control group.

Conclusions: This study will evaluate whether a single bolus administration of concentrated sodium bicarbonate can prevent CIN after emergency PCI.

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© 2023, THE JAPANESE CIRCULATION SOCIETY

This article is licensed under a Creative Commons [Attribution-NonCommercial-NoDerivatives 4.0 International] license.
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