VolumE maNagement Under Body Composition Monitoring in Critically Ill patientS on CRRT

Study Overview
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Brief Summary
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Although monitoring fluid balance for continuous renal replacement therapy-treated patients is an important issue, most physicians usually use conventional methods such as the difference between the amount of intake and output (I & O), which is not objective way. Meanwhile, bioimpedance electrical vector analysis presents the patients' fluid status with more objective data. Thus, the investigators will investigate the clinical benefit for monitoring fluid balance when the investigators use InBody S10, one of representative bioimpedance electrical vector analysis, compared with conventional methods among the patients who need continuous renal replacement therapy.

Detailed Description
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Although monitoring fluid balance for continuous renal replacement therapy-treated patients is an important issue, most physicians usually use conventional methods such as the difference between the amount of intake and output (I & O), which is not objective way. Meanwhile, bioimpedance electrical vector analysis presents the patients' fluid status with more objective data. Thus, the investigators will investigate the clinical benefit for monitoring fluid balance by using InBody S10 (0, 1, 2-day, and 7-day from CRRT initiation), one of representative bioimpedance electrical vector analysis, compared with conventional methods among the patients who need continuous renal replacement therapy.

Official Title
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VolumE maNagement Under Body Composition Monitoring in Critically Ill patientS on CRRT; Randomized-controlled Trial (VENUS Trial)

Conditions
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Renal Dialysis, Fluid Overload

Intervention / Treatment
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* Device: InBody group
* Other: IO group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be eligible for INCLUSION in the study if ALL the following criteria are met; The treating clinician believes that the patient requires continuous renal replacement therapy for acute renal failure. The treating clinicians anticipate treating the patient with continuous renal replacement therapy for at least 72 hours. Informed consent has been obtained. The patient fulfills ONE of the following clinical criteria for initiating continuous renal replacement therapy: urine output < 100 ml/6 hr that has been unresponsive to fluid resuscitation measures K+> 6.5 mmol/L pH < 7.2 Urea > 25 mmol/L Clinically significant organ edema in the setting of acute kidney injury Patients who are over 5% of fluid overload or their total body water/height^2 ≥13 L/m^2 Exclusion Criteria: Patients will be EXCLUDED from the study if, in the opinion or knowledge of the responsible clinician ANY of the following criteria are present: Patient age is < 18 years Death is imminent (<24 hours) There is a strong likelihood that the study treatment will not be continued in accordance with the study protocol. The patient has been treated with continuous renal replacement therapy or other dialysis previously during the same hospital admission. The patient has been on maintenance dialysis prior to the current hospitalization. Any other major illness that, in the investigator's judgement, will substantially increase the risk associated with the subject's participation in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One is control for the patients under conventional methods (I/O based fluid monitoring). The other is case for the patients under Inbody S10 methods.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IO group<br>Fluid overload will be removed in the patients who received continuous renal replacement therapy, but the amount of fluid removal are guided by the intake-output balance. | Other: IO group<br>* Fluid removal are guided by intake-output balance.<br>|
| Experimental: InBody group<br>Fluid overload will be removed in the patients who received continuous renal replacement therapy, but the amount of fluid removal are guided by the bioimpedance analysis (InBody S10). | Device: InBody group<br>* As one of representative BIVA, it provides the patients' fluid status with more objective data such as TBW, ECW, ICW, etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate reaching euvolemia | To compare how many rates the two groups reach the euvolemia at 7 days from CRRT initiation | 7 days from CRRT initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes (28-, 60-, 90-day mortality) | To compare the mortality rates between the two groups | 28-, 60-, or 90-days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluid management, conventional method, InBody S10, CRRT