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

NCT02446535 | Unknown DMC

• 1 other identifier: MiulliGH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Background Very recently, a test aimed at assessing dry weight (DW) in hemodialysis (HD) patients has been developed, the "resistance stabilization test" (REST) Aim of the study To verify if BIA-based DW (BIA DW) control is truly superior to current volume management in HD patients. Protocol of the study DW determined with clinical methods (Clinical DW) is the gold standard by definition: Clinical DW is determined under strict clinical surveillance by the same attending physician. He will be helped by a clinical score of volume state about symptoms and signs of hypo- or hypervolemia. The physician is asked to adjust the DW of the candidates until their clinical score reaches zero before the BIA measurement. This Clinical DW will be compared with BIA DW, as obtained after performing REST Phases of the study The protocol study includes three sequential phases:

1. 1.the Clinical DW is the gold standard by definition. Items of form B must be strictly applied until score = 0 is achieved;
2. 2.The Clinical DW as indicated by the score = 0 becomes the target DW of the next standard HD session, in which BIA measurements are performed: R values are recorded continuously during the session.
3. 3.REST is performed the following dialysis session. As per protocol, these dialysis sessions may be one or more than one, until flattening of the curve of the ratio R0/Rt (R0 is R at time 0 and Rt is R at a given time t during the HD session) of less than + 1% over 20 minutes in the presence of ongoing UF, is obtained.
4. 4.the Clinical and the BIA DW will be very similar ( \< + 0.5 kg). Therefore, a reciprocal validation of the two methods for that specific patient has been obtained;
5. 5.the Clinical and the BIA DW are different ( \> + 0.5 kg). If the BIA DW will be confirmed in the following six dialysis sessions, it means that the gold standard DW for that patient is the BIA DW.

Conditions

Uremia; Complication of Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Bioimpedance (BIA) appears to be useful for the achievement of DW. Resistance (R, measured in Ohm) is a basic property of BIA. Postdialytic weight (kg) is measured with a bed scale. R and DW will be reported in the outcome measure data tables

  up to 4 weeks

Study Arms (1)

BIA DW assessment

EXPERIMENTAL

All patients have undergone a Clinical DW assessment. Then, they undergo HD sessions in which BIA DW is determined reducing body weight (kg): when flattening of the BIA resistance occurs, the BIA DW is achieved and compared with the Clinical DW

Other: achievement of the DW by means of the BIA DW (RE.S.T.)

Interventions

achievement of the DW by means of the BIA DW (RE.S.T.) OTHER

BIA DW assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients older than 18 years
• maintenance HD three times weekly.

You may not qualify if:

• dialysis vintage \< 3 months
• overt edema
• liver cirrhosis
• cardiac failure
• serum albumin \< 3 g/dl
• pregnancy
• metallic implants or a pacemaker
• limb amputation.

Sponsors & Collaborators

• Miulli General Hospital: lead

Study Sites (1)

Nephrology and dialysis unit Miulli General Hospital

Acquaviva delle Fonti, Bari, 70100, Italy

RECRUITING

MeSH Terms

Conditions

Uremia

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Carlo Basile, MD

CONTACT

080 3054964; basile.miulli@libero.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director of the Division of Nephrology

Study Record Dates

• First Submitted: April 26, 2015
• First Posted: May 18, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: May 18, 2015

Record last verified: 2015-05

Locations

IT (1)