VolumE maNagement Under body composition monitoring in critically ill patientS on CRRT:Randomized-controlled trial (VENUS trial)

VolumE maNagement Under body composition monitoring in critically ill patientS on CRRT; Randomized-controlled trial (VENUS trial)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0002534

Enrollment

208

Registered

2017-11-16

Start date

2017-07-13

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

None listed

Interventions

Medical Device : Randomly, the enrolled patients will be divided into two groups (Control vs. Inbody). The control group will be measured for their fluid status with conventional methods

[total amount of input fluid - total amount of output fluid], whereas inbody group will be checked for their fluid status with inbody indices

[TBW/H2, ECW/TCW ratio, Phase angle]. The primary outcome is to compare the reaching rate to normal fluid status between the two groups after 1 week from CRRT initiation. Moreover, we wish to investig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patient Inclusion Criteria; Patients will be eligible for INCLUSION in the study if ALL the following criteria are met; ? The treating clinician believes that the patient requires CRRT for acute renal failure. ? The treating clinicians anticipate treating the patient with CRRT for at least 72 hours. ? Informed consent has been obtained. ? The patient fulfils ONE of the following clinical criteria for initiating CRRT: Oliguria (urine output 6.5mmol/L) - Severe academia (pH 25mmol/L - Creatinine > 300umol/L - Clinically significant organ edema in the setting of ARF (eg: lung)

Exclusion criteria

Exclusion criteria: 1) Patient 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: ? Patient age is < 18years ? Death is imminent (<24 hours) ? There is a strong likelihood that the study treatment will not be continued in accordance with the study protocol. ? The patient has been treated with CRRT or other dialysis previously during the same hospital admission. ? The patient has been on maintenance dialysis prior to the current hospitalization. ? 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

Measure	Time frame
To investigate the mortality rate between Inbody S10 and Control groups;To investigate the reaching rate to euvolemia after 1 week from CRRT initiation	—

Secondary

Measure	Time frame
To investigate the safety for Inbody S10	—

Countries

Korea, Republic of

Contacts

Public ContactSejoong Kim

Seoul National University Bundang Hospital

sejoong@snubh.org+82-31-787-7051

Outcome results