Probing the Dry Weight by Bioimpedance: The Resistance Stabilization Test

Not Applicable

• Conditions: Uremia
• Interventions: Device: BIA DW

• Registration Number: NCT02606955
• Lead Sponsor: Miulli General Hospital

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

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-10-08
• Status Verified: 2015-11
• Study First Submitted QC: 2015-11-15
• Last Update Submitted: 2015-11-15
• Study First Posted: 2015-11-17
• Last Update Posted: 2015-11-17
• Primary Completion: 2016-03
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BIA REST	BIA DW	BIA DW assessment

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Nephrology and dialysis unit Miulli General Hospital; 🇮🇹 Acquaviva delle Fonti, Bari, Italy

Divisionof Nephrology; 🇮🇹 Solofra, Italy