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

Hyung Jung Oh, Jung Nam An, Sohee Oh, Harin Rhee, Jung Pyo Lee, Dong Ki Kim, Dong-Ryeol Ryu, Sejoong Kim, Hyung Jung Oh, Jung Nam An, Sohee Oh, Harin Rhee, Jung Pyo Lee, Dong Ki Kim, Dong-Ryeol Ryu, Sejoong Kim

Abstract

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 patient's 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.

Keywords: Bioimpedance analysis (InBody S10 (InBody®) Seoul, Korea); Continuous renal replacement therapy (CRRT); Fluid balance.

Conflict of interest statement

Ethics approval and consent to participate

The study will be performed in accordance with the Declaration of Helsinki, as amended by the 59th World Medical Association General Assembly in 2008. All the participants will provide signed, informed, written consent, stating that participation is voluntary and can be withdrawn at any time. Approval for the study has been obtained from the Institutional Review Board of Seoul National University Bundang Hospital (B-1702/383–003), Seoul National University Hospital (J-1705-080-855), Seoul National University Boramae Medical Center (20,170,516/20–2017-2/062), Ewha Womans University Mokdong Hospital (EUMC 2017–05–049-008). The trial protocol has been registered at http://www.clinicaltrials.gov (NCT03330626) (Ethical Approval Document).

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The overall study algorithm. After enrollment, InBody S10 (InBody®, Seoul, Korea) will be used to measure fluid status at 0, 1, 2, and 7 days after the initiation of the continuous renal replacement therapy (CRRT) in InBody S10-based fluid management group, but at 0 and 7 days in fluid management guided by a generally used quantification method. Abbreviations: AKI acute kidney injury, CRRT continuous renal replacement therapy, D0 the day of CRRT initiation, D1, 2 and 7 1, 2 and 7 days from the day of CRRT initiation, respectively
Fig. 2
Fig. 2
Schedule of enrollment, interventions, and assessments according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline. Abbreviations: TBW total body water, ICW intracellular water, ECW extracellular water, TBW/H2 total body water/height2

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