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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Renal Dialysis Fluid Overload Device: InBody group Other: IO group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
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
Official Title: VolumE maNagement Under Body Composition Monitoring in Critically Ill patientS on CRRT; Randomized-controlled Trial (VENUS Trial)
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Clinical outcomes (28-, 60-, 90-day mortality) [ Time Frame: 28-, 60-, or 90-days ]
    To compare the mortality rates between the two groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330626


Contacts
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Contact: Sejoong Kim, MD,PhD +82-10-9496-4899 sejoong@snubh.org
Contact: Hyungjung Oh, MD,PhD +82-2-2650-2907 ohjmd@naver.com

Locations
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Korea, Republic of
Bundang Seoul National University Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Sejoong Kim, MD,PhD    +82-10-94964899    sejoong2@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
SMG-SNU Boramae Medical Center
Ewha Womans University Mokdong Hospital
Investigators
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Principal Investigator: Sejoong Kim, MD,PhD Department of Internal Medicine, Bundang Seoul National University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sejoong Kim, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03330626    
Other Study ID Numbers: VENUS
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sejoong Kim, Seoul National University Hospital:
Fluid management
conventional method
InBody S10
CRRT
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes