Skip to content

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?

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02606955
Enrollment
60
Registered
2015-11-17
Start date
2015-02-28
Completion date
2016-12-31
Last updated
2015-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uremia

Keywords

Bioimpedance, Dry weight, Hemodialysis, Resistance

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

Detailed description

Probing the dry weight (DW) was largely dependent on clinical subjective estimates until recently. New bedside non-invasive tools have been developed with the aim of providing more objective information on volume status and guiding physicians in the quest for DW. Among them, bioimpedance (BIA) appears to be very promising. Very recently, a BIA test aimed at assessing DW in hemodialysis (HD) patients has been developed, the REsistance Stabilization Test (REST). It is called BIA DW. Its rationale is based on the achievement of the flattening of the curve of the ratio R0/Rt (R0 is resistance at time 0 and Rt is resistance at a given time t during the HD session) of less than + 1% over 20 minutes in the presence of ongoing ultrafiltration. Study protocol: the Clinical DW is the gold standard by definition. It is determined under strict clinical surveillance by the same attending physician. She/he will be helped by a clinical score of volume state about symptoms and signs of hypo- or hypervolemia. Then, this Clinical DW will be compared with BIA DW, as obtained after performing REST

Interventions

DEVICEBIA DW

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).

Sponsors

Miulli General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* stable uremic patients * thrice weekly hemodialysis treatment * start of hemodialysis treatment since at least 3 months

Exclusion criteria

* overt edema * liver cirrhosis * cardiac failure * serum albumin \< 3g/dl * pregnancy * metallic implants or a pacemaker * limb amputation

Design outcomes

Primary

MeasureTime frame
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

Countries

Italy

Contacts

Primary ContactValentina Vigo, MD
vigovale2@libero.it0803054496
Backup ContactPiero Lisi, MD
pierolisi76@libero.it0803054347

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026