Using bedside ultrasound to study fluid status and blood pressure drops during haemodialysis

ISRCTN	ISRCTN80571205
DOI	https://doi.org/10.1186/ISRCTN80571205
Sponsor	Université Libre de Bruxelles
Funder	Investigator initiated and funded

Submission date: 04/07/2026
Registration date: 06/07/2026
Last edited: 06/07/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Samuel Larsen
Principal investigator, Scientific

808 route de Lennik
Brussels
1070
Belgium

ORCID ID	0000-0002-7454-5930
Email	samuel.larsen@hubruxelles.be

Prof Thomas Baudoux
Public, Principal investigator, Scientific

808 route de Lennik
Brussels
1070
Belgium

Phone	+33749507812
Email	thomas.baudoux@hubruxelles.be

Study information

Primary study design	Observational
Observational study design	Cohort study
Scientific title	Ultrasound-guided haemodynamic profiling in haemodialysis patients: a single-centre prospective observational study
Study objectives	1. To describe pre- and post-dialysis ultrasound-derived haemodynamic profiles in adults receiving maintenance haemodialysis, including cardiac ultrasound, lung ultrasound and modified VEXUS venous congestion parameters. 2. To assess the within-patient association between pre-dialysis ultrasound parameters and same-session intradialytic hypotension. 3. To describe whether delayed disclosure of ultrasound findings would have changed treating physicians’ intended management. 4. To explore associations between serial ultrasound trajectories and longitudinal clinical outcomes, including hospitalisation, cardiovascular events and mortality.
Ethics approval(s)	Approved 18/06/2026, Ethics Committee Erasme Hospital (808 route de Lennik, Brussels, 1070, Belgium; +322555 37 07; comite.ethique.hub @hubruxelles.be), ref: P2026/298 / B4062026000128
Health condition(s) or problem(s) studied	End-stage kidney disease treated with maintenance haemodialysis; intradialytic hypotension and fluid overload/haemodynamic instability during haemodialysis.
Methodology	This is a single-centre prospective observational cohort study in adult patients receiving maintenance haemodialysis. After written informed consent, participants undergo study assessments during routine dialysis care. At baseline, month 3, month 6 and month 9, a trained operator performs multi-organ point-of-care ultrasound immediately before and after one haemodialysis session. The ultrasound assessment includes focused cardiac ultrasound, lung ultrasound B-line assessment and a modified VEXUS venous congestion assessment using inferior vena cava, hepatic vein and portal vein measurements. Routine haemodialysis proceeds unchanged. No study-mandated therapeutic algorithm is applied, and the study team does not require or recommend changes to the dialysis prescription on the basis of ultrasound findings. Session-level clinical data, intradialytic blood-pressure recordings, symptoms, ultrafiltration data, dialysate prescription and nursing interventions are recorded from routine care and the case report form. When clinically feasible and safe, additional event-triggered ultrasound may be performed during or immediately after intradialytic hypotension, suspected clinically significant fluid overload or suspected underestimated dry weight. For scheduled sessions, the treating physician completes a brief questionnaire before disclosure of the study ultrasound findings and again after delayed disclosure, after the dialysis session has finished and intradialytic outcome data have been recorded, except for prespecified emergency findings. Each participant is followed for 12 months for hospitalisations, cardiovascular events and mortality.
Intervention type	Other
Primary outcome measure(s)	Ultrasound-derived haemodynamic profile measured using ultrasound assessment at 0, 3, 6 and 9 months
Key secondary outcome measure(s)
Completion date	17/07/2027

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	99 Years
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. Adults aged 18 years or older 2. Receiving thrice-weekly chronic haemodialysis for end-stage kidney disease 3. Receiving haemodialysis treatment at the study centre 4. Able and willing to provide written informed consent
Key exclusion criteria	1. Unable safely to undergo ultrasound procedures or follow the protocol, for example because of an open chest wound or severe skin infection at probe sites 2. Cognitive inability to provide informed consent without a legal representative 3. Pregnancy 4. Prisoner status or other vulnerable status preventing freely given consent 5. Peritoneal dialysis 6. If a participant receives a kidney transplant or transfers care during the study, active participation ends from that point; data collected up to that time remain included
Date of first enrolment	12/07/2026
Date of final enrolment	17/07/2027

Locations

Countries of recruitment

Belgium

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version 2.0	11/06/2026	06/07/2026	No	No

Additional files

49840_Protocol_v2.0_11June2026.pdf: Protocol file

Editorial Notes

06/07/2026: Study’s existence confirmed by the Ethics Committee Erasme Hospital, Belgium.