Probing the Dry Weight by Bioimpedance: The Resistance Stabilization Test

Sponsor

Miulli General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02606955

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Uremia	Device: BIA DW	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Probing the Dry Weight (DW) by Bioimpedance (BIA): Which is the Gold Standard Between Clinical DW and BIA DW?

Study Start Date :

Feb 1, 2015

Anticipated Primary Completion Date :

Mar 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BIA REST BIA DW assessment	Device: 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). Other Names: BIA Resistance Stabilization Test (REST)

Arm

Intervention/Treatment

Experimental: BIA REST

BIA DW assessment

Device: 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).

Other Names:

BIA Resistance Stabilization Test (REST)

Outcome Measures

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). [up to 4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nephrology and dialysis unit Miulli General Hospital	Acquaviva delle Fonti	Bari	Italy	70100
2	Divisionof Nephrology	Solofra		Italy

Sponsors and Collaborators

Miulli General Hospital

Investigators

Principal Investigator: Carlo Basile, MD, Mulli General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Carlo Basile, M.D., Scientific Director of the Division of Nephrology, Miulli General Hospital

ClinicalTrials.gov Identifier:

NCT02606955

Other Study ID Numbers:

REST./COLLABORATIVE STUDY

First Posted:

Nov 17, 2015

Last Update Posted:

Nov 17, 2015

Last Verified:

Nov 1, 2015

Keywords provided by Carlo Basile, M.D., Scientific Director of the Division of Nephrology, Miulli General Hospital

Additional relevant MeSH terms:

Uremia

Study Results

No Results Posted as of Nov 17, 2015