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Clinical Trials/NCT03330626
NCT03330626
Unknown
Not Applicable

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

Seoul National University Hospital1 site in 1 country244 target enrollmentJuly 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Dialysis
Sponsor
Seoul National University Hospital
Enrollment
244
Locations
1
Primary Endpoint
The rate reaching euvolemia
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
December 31, 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sejoong Kim

Associate Professor

Seoul National University Hospital

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

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Study Sites (1)

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