Clinical trial NCT03330626: VolumE maNagement Under Body Composition Monitoring in Critically Ill patientS on CRRT
Official title: VolumE maNagement Under Body Composition Monitoring in Critically Ill patientS on CRRT; Randomized-controlled Trial (VENUS Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Dialysis
Fluid Overload
Keywords: Fluid management
conventional method
InBody S10
CRRT
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: SMG-SNU Boramae Medical Center
name: Ewha Womans University Mokdong Hospital
First posted: 2017-11-06
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Patients will be eligible for INCLUSION in the study if ALL the following criteria are met;

  1. The treating clinician believes that the patient requires continuous renal replacement therapy for acute renal failure.
  2. The treating clinicians anticipate treating the patient with continuous renal replacement therapy for at least 72 hours.
  3. Informed consent has been obtained.
  4. 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
  5. 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:

  1. Patient age is \< 18 years
  2. Death is imminent (\<24 hours)
  3. There is a strong likelihood that the study treatment will not be continued in accordance with the study protocol.
  4. The patient has been treated with continuous renal replacement therapy or other dialysis previously during the same hospital admission.
  5. The patient has been on maintenance dialysis prior to the current hospitalization.
  6. Any other major illness that, in the investigator's judgement, will substantially increase the risk associated with the subject's participation in this study.

Primary outcomes:
measure: The rate reaching euvolemia
timeFrame: 7 days from CRRT initiation
Secondary outcomes:
measure: Clinical outcomes (28-, 60-, 90-day mortality)
timeFrame: 28-, 60-, or 90-days
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Bundang Seoul National University Hospital
state: Gyeonggi-do
Study officials:
affiliation: Department of Internal Medicine, Bundang Seoul National University Hospital
name: Sejoong Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oh HJ, An JN, Oh S, Rhee H, Lee JP, Kim DK, Ryu DR, Kim S. VolumE maNagement Under body composition monitoring in critically ill patientS on CRRT: study protocol for a randomized controlled trial (VENUS trial). Trials. 2018 Dec 12;19(1):681. doi: 10.1186/s13063-018-3056-y.