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Probing the Dry Weight by Bioimpedance: The Resistance Stabilization Test

M

Miulli General Hospital

Status

Unknown

Conditions

Uremia

Treatments

Device: BIA DW

Study type

Interventional

Funder types

Other

Identifiers

NCT02606955
REST./COLLABORATIVE STUDY

Details and patient eligibility

About

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

Full 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

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

BIA REST
Experimental group
Description:
BIA DW assessment
Treatment:
Device: BIA DW

Trial contacts and locations

2

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Central trial contact

Piero Lisi, MD; Valentina Vigo, MD

Data sourced from clinicaltrials.gov

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