VolumE maNagement Under body composition monitoring in critically ill patientS on CRRT: study protocol for a randomized controlled trial (VENUS trial)

Background Despite recent technical advances in the management of acute kidney injury (AKI), such as continuous renal replacement therapy (CRRT), intensive care unit mortality is still high, at approximately 40 to 50%. Although several factors have been reported to predict mortality in AKI patients, fluid overload (FO) during CRRT is a well-known predictor of patient survival. However, FO has been mostly quantified as an arithmetical calculation and determined on the basis of the physicians perception. Even though such quantification and assessment provides an easy evaluation of a patients fluid status and is a simple method, it is not applicable unless a detailed record of fluid monitoring is available. Furthermore, the method cannot differentiate excess water in individual water compartments but can only reflect excess total body water. Bioimpedance analysis (BIA) has been used to measure the nutritional component of body composition and is a promising tool for the measurement of volume status. However, there has been no prospective interventional study for fluid balance among CRRT-treated AKI patients using BIA. Therefore, we will investigate the usefulness of fluid management using the InBody S10 (InBody®, Seoul, Korea), a BIA tool, compared with that of generally used quantification methods. Methods/design This will be a multicenter, prospective, randomized controlled trial. A total of 244 patients undergoing CRRT treatment will be enrolled and randomly assigned to receive either to InBody S10-guided management or to fluid management based only on clinical information for 7 days. The primary outcome is to compare the rate of euvolemic status 7 days after the initiation of CRRT, with a secondary outcome being to compare the 28-, 60-, and 90-day mortality rates between the two groups. Discussion This will be the first clinical trial to investigate the effect of using BIA-guided fluid management to achieve euvolemia in CRRT-treated AKI patients. Trial registration ClinicalTrials.gov, ID: NCT03330626. Registered on 6 November 2017.This research was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health and Welfare, Republic of Korea (grant number: HI17C1827) (Funding Documentation)