Efficacy of Short Hydration for Intermediate to High-Dose Cisplatin-Based Chemotherapy for Outpatients: SHORTCIS Trial

Abstract

Objective: Supporting data exists concerning short hydration to prevent cisplatin-induced nephrotoxicity. However, only a few studies exist. Further, data remains limited, comprising mostly retrospective data. Therefore, the study would like to evaluate the efficacy of short hydration using a prospective cohort study. Materials and Methods: This is a prospective cohort non-randomized controlled study in patients receiving intermediate to high doses of cisplatin. Short hydration was set as the intervention arm, while conventional hydration was set as the controlled arm. The consecutive estimates glomerular filtration rates (eGFR) were compared at baseline, Week 3, Week 6, Week 9, Week 12, and Week 15 for both groups by using multilevel regression analysis with the random-effects model with double adjustment (propensity score and confounding adjustment) was used. The trial was registered with the Thai Registry of Clinical Trials, SHORTCIS ThaiClinicalTrials.org, number TCTR20210128002. Results: 30 patients were registered. 14 were assigned to a short hydration group, while 16 were assigned to a conventional hydration group. The levels of consecutive eGFR of the group receiving short hydration were stable (regression coefficients 0.05), while the levels of consecutive eGFR of the group receiving conventional hydration were declined (regression coefficients -1.94). The multilevel regression analysis of consecutive eGFR between conventional group and short hydration group when adjusted for random-effects parameters and double adjustment were significantly different (p-value = 0.001). When analyzing the relationship of received short hydration, it could significantly reduce the risk of nephrotoxicity as well, i.e. acute kidney injury (odds ratio 0.06, 95%CI 0.003, 0.990, p-value 0.049). Conclusion: Short hydration was more efficient for preventing nephrotoxicity than conventional hydration protocols in patients receiving intermediate to high doses of cisplatin