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
Affiliations
Hyung Ah Jo
Department of Internal Medicine, Seoul National University College of Medicine
Sehoon Park
Department of Biomedical Sciences, Seoul National University College of Medicine
Chan-Duck Kim
Department of Internal Medicine, Kyungpook National University Hospital
Hee-Yeon Jung
Department of Internal Medicine, Kyungpook National University Hospital
Jang-Hee Cho
Department of Internal Medicine, Kyungpook National University Hospital
Ran-hui Cha
Department of Internal Medicine, National Medical Center
Ea Wha Kang
Department of Internal Medicine, National Health Insurance Service Ilsan Hospital
Tae Ik Chang
Department of Internal Medicine, National Health Insurance Service Ilsan Hospital
Sejoong Kim
Department of Internal Medicine, Seoul National University Bundang Hospital
Hyung-Jong Kim
Department of Internal Medicine, Bundang CHA Medical Center, CHA University
Byung Ha Chung
Department of Internal Medicine, Seoul St. Mary’s Hospital, The Catholic University of Korea
Jung Pyo Lee
Department of Internal Medicine, Seoul National University Boramae Medical Center
Jung Tak Park
Department of Internal Medicine, Yonsei University College of Medicine
Seung Hyeok Han
Department of Internal Medicine, Yonsei University College of Medicine
Tae-Hyun Yoo
Department of Internal Medicine, Yonsei University College of Medicine
Dong-Ryeol Ryu
Department of Internal Medicine, Ewha Womans University Mokdong Hospital
Sung Jin Moon
Department of Internal Medicine, Catholic Kwandong University International St. Mary’s Hospital
Jae Hyun Chang
Department of Internal Medicine, Gachon University Gil Medical Center
Dong Ki Kim
Department of Internal Medicine, Seoul National University College of Medicine
Kwon Wook Joo
Department of Internal Medicine, Seoul National University College of Medicine
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.
