Renal DialysisNCT03330626
VolumE maNagement Under Body Composition Monitoring in Critically Ill patientS on CRRT
A study testing InBody group and IO group in people with Renal Dialysis and Fluid Overload, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Dialysis, Fluid Overload
- What is being tested?
- InBody group and IO group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Bundang Seoul National University Hospital
Seongnam-si, Gyeonggi-do, 13620
Sejoong Kim, MD,PhD, +82-10-94964899, sejoong2@snu.ac.kr
About this study
Official title: VolumE maNagement Under Body Composition Monitoring in Critically Ill patientS on CRRT; Randomized-controlled Trial (VENUS Trial)
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.
Read the 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
- Being tested
- InBody group, IO group
- Keywords
- Fluid management, conventional method, InBody S10, CRRT
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InBody groupDevice
As one of representative BIVA, it provides the patients' fluid status with more objective data such as TBW, ECW, ICW, etc.
IO groupOther
Fluid removal are guided by intake-output balance.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: InBody group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate reaching euvolemia
To compare how many rates the two groups reach the euvolemia at 7 days from CRRT initiation
Measured: 7 days from CRRT initiation
Secondary outcomes (1)
Clinical outcomes (28-, 60-, 90-day mortality)
To compare the mortality rates between the two groups
Measured: 28-, 60-, or 90-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Jul 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, Ewha Womans University Mokdong Hospital
- Responsible party
- Principal investigator, Sejoong Kim, Seoul National University Hospital
- Investigators
- Sejoong Kim, MD,PhD, Principal investigator, Department of Internal Medicine, Bundang Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330626
- Sponsor's protocol ID
- VENUS
- Status last verified
- Oct 2017
- First submitted
- 1 Jul 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30541593
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VolumE maNagement Under Body Composition Monitoring in Critically Ill patientS on CRRT; Randomized-controlled Trial (VENUS Trial)
- ClinicalTrials.gov ID
- NCT03330626
- Acronym / sponsor ID
- VENUS
- Conditions
- Renal Dialysis, Fluid Overload
- Keywords
- Fluid management, conventional method, InBody S10, CRRT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, Ewha Womans University Mokdong Hospital
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| IO group | Active comparator | Other: IO groupFluid 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. |
| InBody group | Experimental | Device: InBody groupFluid 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients will be eligible for INCLUSION in the study if ALL the following criteria are met;
- urine output < 100 ml/6 hr that has been unresponsive to fluid resuscitation measures
Key exclusion criteria (7 listed)
- Patients will be EXCLUDED from the study if, in the opinion or knowledge of the responsible clinician ANY of the following criteria are present:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InBody groupAs one of representative BIVA, it provides the patients' fluid status with more objective data such as TBW, ECW, ICW, etc. | Device | InBody group |
| IO groupFluid removal are guided by intake-output balance. | Other | IO group |
Primary outcome
The rate reaching euvolemia
Time frame: 7 days from CRRT initiation
To compare how many rates the two groups reach the euvolemia at 7 days from CRRT initiation
1 secondary outcome
Clinical outcomes (28-, 60-, 90-day mortality)
Time frame: 28-, 60-, or 90-days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 30541593Oh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sejoong Kim, MD,PhD principal investigator
Department of Internal Medicine, Bundang Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InBody group and IO group in people with Renal Dialysis and Fluid Overload, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sejoong Kim, MD,PhD (+82-10-9496-4899, sejoong@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate reaching euvolemia (time frame: 7 days from CRRT initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03330626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.