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BIS-guided Fluid Management in HD Patients

NCT05272800 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-03-24

No results posted yet for this study

Summary

Hemodialysis (HD) is life-sustaining in kidney failure. However, adequate fluid status depends on precise estimation of dry weight (DW), which is a goal difficult to achieve. This randomized open label controlled parallel-group trial aims to compare spectroscopy bioimpedance (BIS) guided DW estimation with clinical evaluation alone. Maintenance HD patients above 18 years old were randomized to monthly clinical evaluation (CE) alone or added to twice a year BIS-guided DW estimation. Randomization was performed through random number table. Follow-up lasted up to two years. Primary outcome was survival time and secondary outcomes were rate of hospital admissions, systolic and diastolic blood pressure (BP) change and number of prescribed antihypertensive drugs.

Conditions

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.

Sponsors & Collaborators

  • Catholic University of Pelotas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-09-01
Completion
2021-09-01

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05272800 on ClinicalTrials.gov