Probing the Dry Weight by Bioimpedance: The Resistance Stabilization Test

Uremia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02606955
• Other study ID #: REST./COLLABORATIVE STUDY
• Status: Recruiting
• Phase: N/A
• First received: October 8, 2015
• Last updated: November 15, 2015
• Start date: February 2015
• Est. completion date: December 2016

Study information

• Verified date: November 2015
• Source: Miulli General Hospital
• Contact: Valentina Vigo, MD
• Phone: 0803054496
• Email: vigovale2[@]libero.it
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uremia

Intervention

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).

Locations

Country	Name	City	State
Italy	Nephrology and dialysis unit Miulli General Hospital	Acquaviva delle Fonti	Bari
Italy	Divisionof Nephrology	Solofra

Sponsors (1)

Lead Sponsor	Collaborator
Miulli General Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No