Balanced Salt Solution Versus 0.9% Saline Infusion for Prevention of Contrast-induced Acute Kidney Injury (BASIC Trial)

Summary

As iodinate contrast media (CM) has been widely used in current medical practice, contrast induced acute kidney injury (CI-AKI) has been an important issue. Previously, many guidelines suggested prophylaxis protocol using 0.9% saline when CM is administrated to high risk patients. However, recent studies showed that 0.9% saline might induce metabolic acidosis due to its supra-physiologic chloride component, and therefore renal vasoconstriction. In spite of protective effect by volume expansion with saline infusion, this renal vasoconstriction might have conflicting effect on renal function, as hypoxic injury is suspected to be the main cause of CI-AKI. In contrast to 0.9% saline, balanced salt solution has physiologic level of chloride and neutral pH. Also, recent studies proved preventive effect of balanced salt solution for AKI in several clinical settings. Hence, the investigators planned a prospective randomized controlled trial comparing 0.9% saline and balanced salt solution to prevent CI-AKI.

Timeline

Start

2016-11

Primary completion

2019-05

Completion

2020-03

Outcome

Missed primary endpoint

paper The occurrence of CI-AKI in the study (10 [4.2%]) and control (17 [6.8%]) groups was not significantly different (P = 0.27). PMID 32734238 ↗

Publications

• Park S, Kim DK, Jung HY, Kim CD, Cho JH, Cha RH, Jeong JC, Kim S, Kim HJ, Ban TH, Chung BH, Lee JP, Park JT, Han SH, Yoo TH, Ryu DR, Moon SJ, Lee JE, Huh W, Kang EW, Chang TI, Joo KW. Efficacy and Safety of a Balanced Salt Solution Versus a 0.9% Saline Infusion for the Prevention of Contrast-Induced Acute Kidney Injury After Contrast-Enhanced Computed Tomography. Kidney Med. 2020 Feb 21;2(2):189-195. doi: 10.1016/j.xkme.2019.12.003. eCollection 2020 Mar-Apr.
• Jo HA, Park S, Kim CD, Jung HY, Cho JH, Cha RH, Kang EW, Chang TI, Kim S, Kim HJ, Chung BH, Lee JP, Park JT, Han SH, Yoo TH, Ryu DR, Moon SJ, Chang JH, Kim DK, Joo KW. 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. doi: 10.1186/s13063-017-2202-2.

Drugs

Indications