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

Fluid Overload Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03330626
• Other study ID #: VENUS
• Status: Recruiting
• Phase: N/A
• First received: July 1, 2017
• Last updated: October 31, 2017
• Start date: July 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2017
• Source: Seoul National University Hospital
• Contact: Sejoong Kim, MD,PhD
• Phone: +82-10-9496-4899
• Email: sejoong[@]snubh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Fluid Overload
• Renal Dialysis

Intervention

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

Other:
• IO group
Fluid removal are guided by intake-output balance.

Locations

Country	Name	City	State
Korea, Republic of	Bundang Seoul National University Hospital	Seongnam-si	Gyeonggi-do

Sponsors (4)

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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical outcomes (28-, 60-, 90-day mortality)	To compare the mortality rates between the two groups	28-, 60-, or 90-days