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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.
Trials. 2017 Oct 05; 18(1):461.T

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.

Authors+Show Affiliations

Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.Department of Biomedical Sciences, Seoul National University College of Medicine, Seoul, South Korea.Department of Internal Medicine, Kyungpook National University Hospital, Daegu, South Korea.Department of Internal Medicine, Kyungpook National University Hospital, Daegu, South Korea.Department of Internal Medicine, Kyungpook National University Hospital, Daegu, South Korea.Department of Internal Medicine, National Medical Center, Seoul, South Korea.Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, South Korea.Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, South Korea.Department of Internal Medicine, Seoul National University Bundang Hospital, Gyeonggi-do, South Korea.Department of Internal Medicine, Bundang CHA Medical Center, CHA University, Gyeonggi-do, South Korea.Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea.Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, South Korea.Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.Department of Internal Medicine, Ewha Womans University Mokdong Hospital, Seoul, South Korea.Department of Internal Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, South Korea.Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, South Korea.Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea. junephro@gmail.com.

Pub Type(s)

Clinical Trial, Phase II
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

28982378

Citation

Jo, Hyung Ah, et al. "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." Trials, vol. 18, no. 1, 2017, p. 461.
Jo HA, Park S, Kim CD, et al. 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. Trials. 2017;18(1):461.
Jo, H. A., Park, S., Kim, C. D., Jung, H. Y., Cho, J. H., Cha, R. H., Kang, E. W., Chang, T. I., Kim, S., Kim, H. J., Chung, B. H., Lee, J. P., Park, J. T., Han, S. H., Yoo, T. H., Ryu, D. R., Moon, S. J., Chang, J. H., Kim, D. K., & Joo, K. W. (2017). 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. Trials, 18(1), 461. https://doi.org/10.1186/s13063-017-2202-2
Jo HA, et al. 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. Trials. 2017 Oct 5;18(1):461. PubMed PMID: 28982378.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Jo,Hyung Ah, AU - Park,Sehoon, AU - Kim,Chan-Duck, AU - Jung,Hee-Yeon, AU - Cho,Jang-Hee, AU - Cha,Ran-Hui, AU - Kang,Ea Wha, AU - Chang,Tae Ik, AU - Kim,Sejoong, AU - Kim,Hyung-Jong, AU - Chung,Byung Ha, AU - Lee,Jung Pyo, AU - Park,Jung Tak, AU - Han,Seung Hyeok, AU - Yoo,Tae-Hyun, AU - Ryu,Dong-Ryeol, AU - Moon,Sung Jin, AU - Chang,Jae Hyun, AU - Kim,Dong Ki, AU - Joo,Kwon Wook, Y1 - 2017/10/05/ PY - 2016/11/18/received PY - 2017/09/13/accepted PY - 2017/10/7/entrez PY - 2017/10/7/pubmed PY - 2018/6/12/medline KW - Balanced salt solution KW - Computed tomography KW - Contrast-induced acute kidney injury SP - 461 EP - 461 JF - Trials JO - Trials VL - 18 IS - 1 N2 - 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/28982378/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_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2202-2 DB - PRIME DP - Unbound Medicine ER -