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

NCT ID: NCT03330626

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 244 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2019-12-31

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.

Conditions

Renal Dialysis; Fluid Overload

Keywords

Fluid management; conventional method; InBody S10; CRRT

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

IO group

Intervention Type: OTHER

Fluid removal are guided by intake-output balance.

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).

Group Type: EXPERIMENTAL

InBody group

Intervention Type: DEVICE

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

Interventions

InBody group

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

Intervention Type: DEVICE

IO group

Fluid removal are guided by intake-output balance.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: collaborator

SMG-SNU Boramae Medical Center

OTHER

Sponsor Role: collaborator

Ewha Womans University Mokdong Hospital

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sejoong Kim

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sejoong Kim, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Bundang Seoul National University Hospital

Locations

Bundang Seoul National University Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sejoong Kim, MD,PhD

Role: CONTACT

Phone: +82-10-9496-4899

Email: sejoong@snubh.org

Hyungjung Oh, MD,PhD

Role: CONTACT

Phone: +82-2-2650-2907

Email: ohjmd@naver.com

Facility Contacts

Sejoong Kim, MD,PhD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 30541593 (View on PubMed)

Other Identifiers

VENUS

Identifier Type: -

Identifier Source: org_study_id