BIS-guided Fluid Management in HD Patients

NCT05272800 | Completed

• 1 other identifier: 3.484.130
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Kidney Failure; Haemodialysis Fluid Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• Survival

  Survival curve

  two years

Secondary Outcomes (3)

• Hospital Admissions

  two years

• Systolic and Diastolic Blood pressure

  two years

• Anti-hypertensive medication

  two years

Study Arms (2)

BIS Group

EXPERIMENTAL

Dry weight is evaluated monthly by clinical examination and biannually BIS-guided.

Device: Spectroscopy Bioimpedance Analysis

CE Group

ACTIVE COMPARATOR

Dry weight is evaluated monthly by clinical examination alone.

Other: Clinical Examination alone

Interventions

Spectroscopy Bioimpedance Analysis DEVICE

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).

Also known as: BIS

BIS Group

Clinical Examination alone OTHER

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.

Also known as: CE

CE Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CKD diagnosis,
• years or older,
• treated by in-center HD for longer than three months,
• HD treatment in the Dialysis and Transplantation unit of a Brazilian University Hospital.

You may not qualify if:

• less than thrice a week HD session,
• lower limbs amputation,
• pregnancy,
• pacemaker, implantable cardioverter-defibrillator or orthopedic protheses use.

Sponsors & Collaborators

• Catholic University of Pelotas: lead

Study Sites (1)

Hospital Universitário São Francisco de Paula

Pelotas, Rio Grande do Sul, 96020-260, Brazil

Location

Related Publications (1)

• Stigger K, Ribeiro LR, Cordeiro FM, Bohlke M. Incidence of hospital admissions in bioimpedance-guided fluid management among maintenance hemodialysis patients-Results of a randomized controlled trial. Hemodial Int. 2023 Jul;27(3):318-325. doi: 10.1111/hdi.13076. Epub 2023 Apr 17.

  PMID: 37067785 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A randomized open label controlled parallel-group trial aims to compare spectroscopy bioimpedance (BIS) guided DW estimation with clinical evaluation alone.

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: September 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: After conclusion of publication process
• Access Criteria: Public

Locations

BR (1)