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
|Condition or disease||Intervention/treatment||Phase|
|Renal Dialysis Fluid Overload||Device: InBody group Other: IO group||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||244 participants|
|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)|
|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|
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.
- 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
- Clinical outcomes (28-, 60-, 90-day mortality) [ Time Frame: 28-, 60-, or 90-days ]To compare the mortality rates between the two groups
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
|Contact: Sejoong Kim, MD,PhDfirstname.lastname@example.org|
|Contact: Hyungjung Oh, MD,PhDemail@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Sejoong Kim, MD,PhD||Department of Internal Medicine, Bundang Seoul National University Hospital|