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

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

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.

Study Overview

• Status: Unknown
• Conditions: Fluid Overload; Renal Dialysis
• Intervention / Treatment: Other: IO group; Device: InBody group

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
• Enrollment (Anticipated): 244
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sejoong Kim, MD,PhD; Phone Number: +82-10-9496-4899; Email: sejoong@snubh.org
• Study Contact Backup: Name: Hyungjung Oh, MD,PhD; Phone Number: +82-2-2650-2907; Email: ohjmd@naver.com

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Recruiting
      • Bundang Seoul National University Hospital
      • Contact: Sejoong Kim, MD,PhD; Phone Number: +82-10-94964899; Email: sejoong2@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: July 1, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: CRRT; Fluid management; conventional method; InBody S10
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: VENUS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No