BIS-guided Fluid Management in HD Patients

NACompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

September 1, 2019

Primary Completion Date

September 1, 2021

Study Completion Date

September 1, 2021

Conditions
Kidney FailureHaemodialysis Fluid Adverse Reaction
Interventions
DEVICE

Spectroscopy Bioimpedance Analysis

Initial evaluation using Body Composition Monitor (BCM) (Fresenius Medical Care, Bad Homburg, Germany), with information on extracellular (ECW), intracellular (ICW) and total body water. Based on these measurements, the equipment calculates parameters such as overhydration (OH), derived from the difference between the extracellular water measured and that expected for an individual of the same weight and stature in euvolemia. BCM also calculates extra- to intracellular water ratio (E/I). The measurement was performed by previously trained personal before a mid-week HD session, after five minutes of rest in the supine position, using electrodes placed on ipsilateral high and lower limbs. The patient was advised to avoid coffee or any meal 30 minutes before the evaluation. The data obtained was stored in a memory card to be discharged and analyzed with use of an accompanying software (Fluid Management Tool, Fresenius Medical Care).

OTHER

Clinical Examination alone

The clinical evaluation was performed by a nephrologist with hemodialysis expertise and includes blood pressure measurements before and after a dialysis session, lung examination searching for crackles and lower limbs (or sacral region for bedridden patients) for oedema. The aim of the examination is the estimation and/or revaluation of estimated dry weight. The blood pressure was measured using a sphygmomanometer (Tycos, Welch Allyn, EUA) by the auscultatory technique, with the patient seated in the dialysis chair and upper limb extended. The cuff was placed two to three centimeters from cubital fossa, and a stethoscope (Litmann, 3M, EUA) placed over the brachial artery to detect Korotkoff sounds during inflation and disinflation of the sphygmomanometer cuff.

Trial Locations (1)

96020-260

Hospital Universitário São Francisco de Paula, Pelotas

All Listed Sponsors
lead

Catholic University of Pelotas

OTHER

NCT05272800 - BIS-guided Fluid Management in HD Patients | Biotech Hunter | Biotech Hunter