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Probing the Dry Weight by Bioimpedance: The Resistance Stabilization Test

NCT ID: NCT02606955

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-12-31

Brief Summary

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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

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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

Conditions

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Uremia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BIA REST

BIA DW assessment

Group Type EXPERIMENTAL

BIA DW

Intervention Type DEVICE

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).

Interventions

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BIA 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).

Intervention Type DEVICE

Other Intervention Names

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BIA Resistance Stabilization Test (REST)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Miulli General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Carlo Basile, M.D.

Scientific Director of the Division of Nephrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlo Basile, MD

Role: PRINCIPAL_INVESTIGATOR

Mulli General Hospital

Locations

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Nephrology and dialysis unit Miulli General Hospital

Acquaviva delle Fonti, Bari, Italy

Site Status RECRUITING

Divisionof Nephrology

Solofra, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Valentina Vigo, MD

Role: CONTACT

[email protected]
0803054496

Piero Lisi, MD

Role: CONTACT

[email protected]
0803054347

Facility Contacts

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Carlo Basile, Md

Role: primary

[email protected]
00390803054250

Biagio Di Iorio, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25480486 (View on PubMed)

Other Identifiers

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REST./COLLABORATIVE STUDY

Identifier Type: -

Identifier Source: org_study_id