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Probing the Dry Weight by Bioimpedance: The Resistance Stabilization Test

Primary Purpose

Uremia

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
BIA DW
Sponsored by
Miulli General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uremia focused on measuring Bioimpedance, Dry weight, Hemodialysis, Resistance

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nephrology and dialysis unit Miulli General HospitalRecruiting
  • Divisionof NephrologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BIA REST

Arm Description

BIA DW assessment

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
October 8, 2015
Last Updated
November 15, 2015
Sponsor
Miulli General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02606955
Brief Title
Probing the Dry Weight by Bioimpedance: The Resistance Stabilization Test
Official Title
Probing the Dry Weight (DW) by Bioimpedance (BIA): Which is the Gold Standard Between Clinical DW and BIA DW?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Miulli General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremia
Keywords
Bioimpedance, Dry weight, Hemodialysis, Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BIA REST
Arm Type
Experimental
Arm Description
BIA DW assessment
Intervention Type
Device
Intervention Name(s)
BIA DW
Other Intervention Name(s)
BIA Resistance Stabilization Test (REST)
Intervention Description
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).
Primary Outcome Measure Information:
Title
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).
Time Frame
up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valentina Vigo, MD
Phone
0803054496
Email
vigovale2@libero.it
First Name & Middle Initial & Last Name or Official Title & Degree
Piero Lisi, MD
Phone
0803054347
Email
pierolisi76@libero.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Basile, MD
Organizational Affiliation
Mulli General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nephrology and dialysis unit Miulli General Hospital
City
Acquaviva delle Fonti
State/Province
Bari
ZIP/Postal Code
70100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo Basile, Md
Phone
00390803054250
Email
basile.miulli@libero.it
First Name & Middle Initial & Last Name & Degree
Carlo Basile, MD
Facility Name
Divisionof Nephrology
City
Solofra
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Biagio Di Iorio, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25480486
Citation
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.
Results Reference
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Probing the Dry Weight by Bioimpedance: The Resistance Stabilization Test

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