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

Sehoon Park, Dong Ki Kim, Hee-Yeon Jung, Chan-Duck Kim, Jang-Hee Cho, Ran-Hui Cha, Jong Cheol Jeong, Sejoong Kim, Hyung-Jong Kim, Tae Hyun Ban, Byung Ha Chung, Jung Pyo Lee, Jung Tak Park, Seung Hyeok Han, Tae-Hyun Yoo, Dong-Ryeol Ryu, Sung Jin Moon, Jung Eun Lee, Wooseong Huh, Ea Wha Kang, Tae Ik Chang, Kwon Wook Joo, Sehoon Park, Dong Ki Kim, Hee-Yeon Jung, Chan-Duck Kim, Jang-Hee Cho, Ran-Hui Cha, Jong Cheol Jeong, Sejoong Kim, Hyung-Jong Kim, Tae Hyun Ban, Byung Ha Chung, Jung Pyo Lee, Jung Tak Park, Seung Hyeok Han, Tae-Hyun Yoo, Dong-Ryeol Ryu, Sung Jin Moon, Jung Eun Lee, Wooseong Huh, Ea Wha Kang, Tae Ik Chang, Kwon Wook Joo

Abstract

Rationale & objective: We aimed to elucidate whether a balanced salt solution decreases the occurrence of contrast-induced acute kidney injury (CI-AKI) after contrast-enhanced computed tomography (CE-CT) as compared to 0.9% saline solution.

Study design: A randomized clinical trial.

Setting & participants: The study was performed in 14 tertiary hospitals in South Korea. Patients with estimated glomerular filtration rates (eGFRs) < 45 or <60 mL/min/1.73 m2 and additional risk factors (age ≥ 60 years or diabetes) who were undergoing scheduled CE-CT were included from December 2016 to December 2018.

Intervention: An open-label intervention was performed. The study group received a balanced salt solution and the control group received 0.9% saline solution as prophylactic fluids for CE-CT.

Outcomes: The primary outcome was CI-AKI, defined by creatinine level elevation ≥ 0.5 mg/dL or 25% from baseline within 48 to 72 hours after CE-CT. Secondary outcomes included AKI defined based on the KDIGO (Kidney Disease: Improving Global Outcomes) guideline, eGFR changes, death, or requiring dialysis within 6 months after CE-CT.

Results: 493 patients received the study fluids. The control and study groups included 251 and 242 patients, respectively. The occurrence of CI-AKI in the study (10 [4.2%]) and control (17 [6.8%]) groups was not significantly different (P = 0.27). No significant difference was present for the secondary outcomes; AKI by the KDIGO definition (study: 19 [7.9%], control: 27 [10.8%]; P = 0.33), death/dialysis (study: 11 [4.7%], control: 9 [3.7%]; P = 0.74), and eGFR changes (study: 0.1 ± 0.2 mg/dL, control: 0.3 ± 2.8 mg/dL; P = 0.69).

Limitations: This study failed to meet target enrollment.

Conclusions: The risk for CI-AKI was similar after administration of a balanced salt solution and after use of 0.9% saline solution during CE-CT in higher-risk patients.

Funding: This study was funded by CJ Healthcare (CS2015_0046).

Trial registration: Registered at ClinicalTrials.gov with study number NCT02799368.

Keywords: Contrast-induced acute kidney injury; acute kidney injury; acute renal failure; balanced salt solution; computed tomography; fluid; saline.

© 2020 The Authors.

Figures

Graphical abstract
Graphical abstract
Figure 1
Figure 1
The Consolidated Standards of Reporting Trials (CONSORT) study flow diagram. Abbreviations: FAS, full analysis set; PP, per protocol.

References

    1. Weisbord S.D., Mor M.K., Resnick A.L., Hartwig K.C., Palevsky P.M., Fine M.J. Incidence and outcomes of contrast-induced AKI following computed tomography. Clin J Am Soc Nephrol. 2008;3(5):1274–1281.
    1. James M.T., Ghali W.A., Tonelli M. Acute kidney injury following coronary angiography is associated with a long-term decline in kidney function. Kidney Int. 2010;78(8):803–809.
    1. Kim S.M., Cha R.H., Lee J.P. Incidence and outcomes of contrast-induced nephropathy after computed tomography in patients with CKD: a quality improvement report. Am J Kidney Dis. 2010;55(6):1018–1025.
    1. Park S., Kim M.H., Kang E. Contrast-induced nephropathy after computed tomography in stable CKD patients with proper prophylaxis: 8-year experience of outpatient prophylaxis program. Medicine (Baltimore) 2016;95(18):e3560.
    1. KDIGO Clinical practice guideline for acute kidney injury. Kidney Int Suppl. 2012;2(1):116–121.
    1. ACR Committee on Drugs and Contrast Media ACR Manual on Contrast Media. 2016.
    1. Brar S.S., Shen A.Y., Jorgensen M.B. Sodium bicarbonate vs sodium chloride for the prevention of contrast medium-induced nephropathy in patients undergoing coronary angiography: a randomized trial. JAMA. 2008;300(9):1038–1046.
    1. Chowdhury A.H., Cox E.F., Francis S.T., Lobo D.N. A randomized, controlled, double-blind crossover study on the effects of 2-L infusions of 0.9% saline and plasma-lyte(R) 148 on renal blood flow velocity and renal cortical tissue perfusion in healthy volunteers. Ann Surg. 2012;256(1):18–24.
    1. Chowdhury A.H., Cox E.F., Francis S.T., Lobo D.N. A randomized, controlled, double-blind crossover study on the effects of 1-L infusions of 6% hydroxyethyl starch suspended in 0.9% saline (Voluven) and a balanced solution (Plasma Volume Redibag) on blood volume, renal blood flow velocity, and renal cortical tissue perfusion in healthy volunteers. Ann Surg. 2014;259(5):881–887.
    1. Shaw A.D., Schermer C.R., Lobo D.N. Impact of intravenous fluid composition on outcomes in patients with systemic inflammatory response syndrome. Crit Care. 2015;19:334.
    1. Yunos N.M., Bellomo R., Hegarty C., Story D., Ho L., Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012;308(15):1566–1572.
    1. Semler M.W., Wanderer J.P., Ehrenfeld J.M. Balanced crystalloids versus saline in the intensive care unit. The SALT randomized trial. Am J Respir Crit Care Med. 2017;195(10):1362–1372.
    1. Nijssen E.C., Rennenberg R.J., Nelemans P.J. Prophylactic hydration to protect renal function from intravascular iodinated contrast material in patients at high risk of contrast-induced nephropathy (AMACING): a prospective, randomised, phase 3, controlled, open-label, non-inferiority trial. Lancet. 2017;389(10076):1312–1322.
    1. Jo H.A., Park S., Kim C.D. 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.
    1. Jeon J., Kim S., Yoo H. Risk prediction for contrast-induced nephropathy in cancer patients underoing computed tomography under preventive measures. J Oncol. 2019;2019:8736163.
    1. Barrett B.J., Parfrey P.S. Preventing nephropathy induced by contrast medium. N Engl J Med. 2006;354(4):379–386.
    1. Rihal C.S., Textor S.C., Grill D.E. Incidence and prognostic importance of acute renal failure after percutaneous coronary intervention. Circulation. 2002;105(19):2259–2264.
    1. Mitchell A.M., Kline J.A., Jones A.E., Tumlin J.A. Major adverse events one year after acute kidney injury after contrast-enhanced computed tomography. Ann Emerg Med. 2015;66(3):267–274.
    1. Zoungas S., Ninomiya T., Huxley R. Systematic review: sodium bicarbonate treatment regimens for the prevention of contrast-induced nephropathy. Ann Intern Med. 2009;151(9):631–638.
    1. Choi H., Jo H.A., Park S. 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;18:461.

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