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

• ClinicalTrials.gov Identifier: NCT03330626
• Recruitment Status: Unknown
• First Posted: November 6, 2017
• Last Update Posted: November 6, 2017
• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University Bundang Hospital; SMG-SNU Boramae Medical Center; Ewha Womans University Mokdong Hospital
• Information provided by (Responsible Party): Sejoong Kim, Seoul National University Hospital

Tracking Information

• First Submitted Date: July 1, 2017
• First Posted Date: November 6, 2017
• Last Update Posted Date: November 6, 2017
• Actual Study Start Date: July 1, 2017
• Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 31, 2017)

The rate reaching euvolemia [ Time Frame: 7 days from CRRT initiation ]

To compare how many rates the two groups reach the euvolemia at 7 days from CRRT initiation

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 31, 2017)

Clinical outcomes (28-, 60-, 90-day mortality) [ Time Frame: 28-, 60-, or 90-days ]

To compare the mortality rates between the two groups

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Renal Dialysis
• Fluid Overload

Intervention

• Device: InBody group
  As one of representative BIVA, it provides the patients' fluid status with more objective data such as TBW, ECW, ICW, etc.
• Other: IO group
  Fluid removal are guided by intake-output balance.

Study Arms

• Active Comparator: IO group
  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.
  Intervention: Other: IO group
• Experimental: InBody group
  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).
  Intervention: Device: InBody group

• Publications *: 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 31, 2017): 244
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2019
• Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT03330626
• Other Study ID Numbers: VENUS
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Sejoong Kim, Seoul National University Hospital
• Study Sponsor: Seoul National University Hospital

Collaborators

• Seoul National University Bundang Hospital
• SMG-SNU Boramae Medical Center
• Ewha Womans University Mokdong Hospital

Investigators

• Principal Investigator: Sejoong Kim, MD,PhD; Department of Internal Medicine, Bundang Seoul National University Hospital

• PRS Account: Seoul National University Hospital
• Verification Date: October 2017