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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

 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 
 TRIALS, Vol.18(1) : 461, 2017-10 
Journal Title
Issue Date
Acute Kidney Injury / chemically induced ; Acute Kidney Injury / diagnosis ; Acute Kidney Injury / prevention & control* ; Acute Kidney Injury / therapy ; Clinical Protocols ; Contrast Media / administration & dosage ; Contrast Media / adverse effects* ; Fluid Therapy / adverse effects ; Fluid Therapy / methods* ; Humans ; Infusions, Intravenous ; Plasma Substitutes / administration & dosage* ; Plasma Substitutes / adverse effects ; Renal Replacement Therapy ; Republic of Korea ; Research Design ; Risk Factors ; Sodium Chloride / administration & dosage* ; Sodium Chloride / adverse effects ; Time Factors ; Tomography, X-Ray Computed / adverse effects* ; Treatment Outcome
Balanced salt solution ; Computed tomography ; Contrast-induced acute kidney injury
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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Park, Jung Tak(박정탁) ORCID logo https://orcid.org/0000-0002-2325-8982
Yoo, Tae Hyun(유태현) ORCID logo https://orcid.org/0000-0002-9183-4507
Han, Seung Hyeok(한승혁) ORCID logo https://orcid.org/0000-0001-7923-5635
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