Probing the Dry Weight by Bioimpedance: The Resistance Stabilization Test
Probing the Dry Weight (DW) by Bioimpedance (BIA): Which is the Gold Standard Between Clinical DW and BIA DW?
1 other identifier
interventional
60
1 country
2
Brief Summary
Clinical methods are fundamental in probing the DW. They must be supported by strict BIA protocols. REST appears to be a (the) brilliant solution in solving the old problem of DW in HD patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2015
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 8, 2015
CompletedFirst Posted
Study publicly available on registry
November 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedNovember 17, 2015
November 1, 2015
1.1 years
October 8, 2015
November 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of the gold standard method for the measurement of DW (in kg) through the comparison of clinical DW (as determined by means of a validated clinical score) and BIA DW (measurement of the resistance in kilohertz).
up to 4 weeks
Study Arms (1)
BIA REST
EXPERIMENTALBIA DW assessment
Interventions
All patients undergo a Clinical DW assessment. Then, they undergo a HD session in which BIA DW (injection of 800 microAmpere at 50 kilohertz alternating sinusoidal current with a standard tetrapolar technique) is determined. BIA DW is determined by performing the REsistance Stabilization Test (REST).
Eligibility Criteria
You may qualify if:
- stable uremic patients
- thrice weekly hemodialysis treatment
- start of hemodialysis treatment since at least 3 months
You may not qualify if:
- overt edema
- liver cirrhosis
- cardiac failure
- serum albumin \< 3g/dl
- pregnancy
- metallic implants or a pacemaker
- limb amputation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Nephrology and dialysis unit Miulli General Hospital
Acquaviva delle Fonti, Bari, 70100, Italy
Divisionof Nephrology
Solofra, Italy
Related Publications (1)
Basile C, Libutti P, Lisi P, Rossi L, Lomonte C. Probing the dry weight by bioimpedance: the resistance stabilization test. J Nephrol. 2015 Aug;28(4):517-20. doi: 10.1007/s40620-014-0159-8. Epub 2014 Dec 6.
PMID: 25480486BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlo Basile, MD
Mulli General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Scientific Director of the Division of Nephrology
Study Record Dates
First Submitted
October 8, 2015
First Posted
November 17, 2015
Study Start
February 1, 2015
Primary Completion
March 1, 2016
Study Completion
December 1, 2016
Last Updated
November 17, 2015
Record last verified: 2015-11