An interventional study of BIA DW in Uremia, sponsored by Miulli General Hospital. Status unknown at 2 sites in Italy. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-17.
Sponsored by Miulli General Hospital · Not applicable, Interventional, and Treatment
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
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
53 studies on the registry are indexed under Uremia; 10 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 38 interventional studies indexed under Uremia.
Browse Uremia studies →Miulli General Hospital is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria
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).
Also known as: BIA Resistance Stabilization Test (REST)
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
This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Miulli General Hospital