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

Primary Purpose

Renal Dialysis, Fluid Overload

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

InBody group

IO group

About this trial

This is an interventional treatment trial for Renal Dialysis focused on measuring Fluid management, conventional method, InBody S10, CRRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Bundang Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

IO group

InBody group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

The rate reaching euvolemia

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

Secondary Outcome Measures

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

To compare the mortality rates between the two groups

Full Information

NCT ID

NCT03330626

First Posted

July 1, 2017

Last Updated

October 31, 2017

Sponsor

Seoul National University Hospital

Collaborators

Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, Ewha Womans University Mokdong Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03330626

Brief Title

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

Official Title

VolumE maNagement Under Body Composition Monitoring in Critically Ill patientS on CRRT; Randomized-controlled Trial (VENUS Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

Collaborators

Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, Ewha Womans University Mokdong Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Dialysis, Fluid Overload

Keywords

Fluid management, conventional method, InBody S10, CRRT

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

244 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IO group

Arm Type

Active Comparator

Arm Description

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.

Arm Title

InBody group

Arm Type

Experimental

Arm Description

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).

Intervention Type

Device

Intervention Name(s)

InBody group

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

IO group

Intervention Description

Fluid removal are guided by intake-output balance.

Primary Outcome Measure Information:

Title

The rate reaching euvolemia

Description

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

Time Frame

7 days from CRRT initiation

Secondary Outcome Measure Information:

Title

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

Description

To compare the mortality rates between the two groups

Time Frame

28-, 60-, or 90-days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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 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 < 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sejoong Kim, MD,PhD

Phone

+82-10-9496-4899

sejoong@snubh.org

First Name & Middle Initial & Last Name or Official Title & Degree

Hyungjung Oh, MD,PhD

Phone

+82-2-2650-2907

ohjmd@naver.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sejoong Kim, MD,PhD

Organizational Affiliation

Department of Internal Medicine, Bundang Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bundang Seoul National University Hospital

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sejoong Kim, MD,PhD

Phone

+82-10-94964899

sejoong2@snu.ac.kr

12. IPD Sharing Statement

Citations:

PubMed Identifier

30541593

Citation

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.

Results Reference

derived

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

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