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

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ClinicalTrials.gov Identifier: NCT03330626
Recruitment Status : Unknown
Verified October 2017 by Sejoong Kim, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
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  ICMJE July 1, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date November 6, 2017
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VolumE maNagement Under Body Composition Monitoring in Critically Ill patientS on CRRT
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE
  • Renal Dialysis
  • Fluid Overload
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 31, 2017)
244
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03330626
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Sejoong Kim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE
  • Seoul National University Bundang Hospital
  • SMG-SNU Boramae Medical Center
  • Ewha Womans University Mokdong Hospital
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP