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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Efficacy and safety of a balanced salt solution versus a 0.9% saline infusion for the prevention of contrast-induced acute kidney injury (BASIC trial): a study protocol for a randomized controlled trial

Authors: Hyung Ah Jo, Sehoon Park, Chan-Duck Kim, Hee-Yeon Jung, Jang-Hee Cho, Ran-hui Cha, Ea Wha Kang, Tae Ik Chang, Sejoong Kim, Hyung-Jong Kim, Byung Ha Chung, Jung Pyo Lee, Jung Tak Park, Seung Hyeok Han, Tae-Hyun Yoo, Dong-Ryeol Ryu, Sung Jin Moon, Jae Hyun Chang, Dong Ki Kim, Kwon Wook Joo

Published in: Trials | Issue 1/2017

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Abstract

Background

Contrast-induced acute kidney injury (CI-AKI) is one of the most common causes of iatrogenic kidney injury and, therefore, its prevention is an important issue. However, whether the administration of 0.9% saline is the optimal prophylaxis method remains uncertain due to its supra-physiologic chloride component. In particular, recent studies suggest that chloride-restricted solutions showed superiority over 0.9% saline in several clinical settings.

Methods/design

The investigators designed a multicenter randomized controlled trial to compare the efficacy of a balanced salt solution and 0.9% saline in CI-AKI prophylaxis. This study will recruit patients who are scheduled for contrast-enhanced computed tomography (CT) scans with CI-AKI prophylaxis. In this study, participants will be randomized into two study arms; the study group will receive a balanced salt solution, and the control group will receive 0.9% saline. Fluids will be administered as designated in the protocol before and after the CT scan, and an evaluation of baseline clinical status will be performed by obtaining blood and urine samples. During the follow-up visits, the incidence of CI-AKI and long-term outcomes, including the start of renal replacement therapy or all-cause mortality, will be assessed.

Discussion

To our knowledge, this study will be the first study assessing the preventive value of a balanced salt solution over 0.9% saline for CI-AKI. If the trial shows that the balanced salt solution is as effective for CI-AKI prophylaxis as 0.9% saline, the use of the balanced salt solution could be promoted due to the reduced possibility of consequent metabolic acidosis compared to 0.9% saline.

Trials registration

ClinicalTrials.gov, ID: NCT02799368. Registered on 14 June 2016.
Appendix
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Metadata
Title
Efficacy and safety of a balanced salt solution versus a 0.9% saline infusion for the prevention of contrast-induced acute kidney injury (BASIC trial): a study protocol for a randomized controlled trial
Authors
Hyung Ah Jo
Sehoon Park
Chan-Duck Kim
Hee-Yeon Jung
Jang-Hee Cho
Ran-hui Cha
Ea Wha Kang
Tae Ik Chang
Sejoong Kim
Hyung-Jong Kim
Byung Ha Chung
Jung Pyo Lee
Jung Tak Park
Seung Hyeok Han
Tae-Hyun Yoo
Dong-Ryeol Ryu
Sung Jin Moon
Jae Hyun Chang
Dong Ki Kim
Kwon Wook Joo
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2202-2

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