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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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03330626
Enrollment
244
Registered
2017-11-06
Start date
2017-07-01
Completion date
2019-12-31
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Overload, Renal Dialysis

Keywords

Fluid management, conventional method, InBody S10, CRRT

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.

Interventions

DEVICEInBody group

As one of representative BIVA, it provides the patients' fluid status with more objective data such as TBW, ECW, ICW, etc.

OTHERIO group

Fluid removal are guided by intake-output balance.

Sponsors

Seoul National University Bundang Hospital
CollaboratorOTHER
SMG-SNU Boramae Medical Center
CollaboratorOTHER
Ewha Womans University Mokdong Hospital
CollaboratorOTHER
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The rate reaching euvolemia7 days from CRRT initiationTo compare how many rates the two groups reach the euvolemia at 7 days from CRRT initiation

Secondary

MeasureTime frameDescription
Clinical outcomes (28-, 60-, 90-day mortality)28-, 60-, or 90-daysTo compare the mortality rates between the two groups

Countries

South Korea

Contacts

Primary ContactSejoong Kim, MD,PhD
sejoong@snubh.org+82-10-9496-4899
Backup ContactHyungjung Oh, MD,PhD
ohjmd@naver.com+82-2-2650-2907

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026