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

NCT03330626 | Unknown DMC

• 1 other identifier: VENUS
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Dialysis; Fluid Overload

Keywords

Fluid management; conventional method; InBody S10; CRRT

Outcome Measures

Primary Outcomes (1)

• The rate reaching euvolemia

  To compare how many rates the two groups reach the euvolemia at 7 days from CRRT initiation

  7 days from CRRT initiation

Secondary Outcomes (1)

• Clinical outcomes (28-, 60-, 90-day mortality)

  28-, 60-, or 90-days

Study Arms (2)

IO group

ACTIVE COMPARATOR

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

InBody group

EXPERIMENTAL

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

Interventions

InBody group DEVICE

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

InBody group

IO group OTHER

Fluid removal are guided by intake-output balance.

IO group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The treating clinician believes that the patient requires continuous renal replacement therapy for acute renal failure.
• The treating clinicians anticipate treating the patient with continuous renal replacement therapy for at least 72 hours.
• Informed consent has been obtained.
• 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
• Patients who are over 5% of fluid overload or their total body water/height\^2 ≥13 L/m\^2

You may not qualify if:

• 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 \< 18 years
• 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 continuous renal replacement therapy 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator
• SMG-SNU Boramae Medical Center: collaborator
• Ewha Womans University Mokdong Hospital: collaborator

Study Sites (1)

Bundang Seoul National University Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 30541593 DERIVED

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sejoong Kim, MD,PhD

  Department of Internal Medicine, Bundang Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sejoong Kim, MD,PhD

CONTACT

+82-10-9496-4899; sejoong@snubh.org

Hyungjung Oh, MD,PhD

CONTACT

+82-2-2650-2907; ohjmd@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2017
• First Posted: November 6, 2017
• Study Start: July 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 6, 2017

Record last verified: 2017-10

Locations

KR (1)