Lung UltrasoundEP8SHNCT05132036
Lung Ultrasound Assessment of Fluid Overload in Haemodialysis Patients
A study testing lung ultrasound in people with Lung Ultrasound and Hemodialysis Complication, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Determination of the hemodialysis ultrafiltration volume is guided by the clinician's estimate of dry weight. A poor estimate of this dry weight may result in insufficient fluid depletion causing a state of volume overload, which may be associated with long-term left ventricular failure, high blood pressure and excess… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Ultrasound, Hemodialysis Complication
- What is being tested?
- lung ultrasound
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years old
- patients on hemodialysis for more than 3 months;
- patients without cardiological or infectious event for at least 3 months;
- patients having at least 2 dialysis session per week;
- patients affiliated with a health insurance plan;
- patients having signed an informed consent.
Who cannot join
- Pulmonary fibrosis or active lung disease;
- residual diuresis over 500 mL per day;
- body mass index (BMI) < 21 and > 28 Kg/m²;
- medical history of major amputation (subgonal or transfemoral);
- pacemaker carrier;
- patients with orthopedic prosthesis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lung Ultrasound Assessment of Fluid Overload in Haemodialysis Patients Using 8 Sites Score
Determination of the hemodialysis ultrafiltration volume is guided by the clinician's estimate of dry weight. A poor estimate of this dry weight may result in insufficient fluid depletion causing a state of volume overload, which may be associated with long-term left ventricular failure, high blood pressure and excess of mortality. The diagnosis of fluid overload in haemodialysis patient is routinely based on clinical examination which consists of cardiopulmonary auscultation and edema palpation of limb member. Clinical examination can be completed by paraclinical examinations, and bioimpedance is an objective tool that assess fluid overload state. This test provides an individualized hydration status and fluid overload based on normal extracellular volume considering body composition. Echocardiography allows an accurate assessment of blood volume status by simultaneous studying left ventricular filling pressures, systolic pulmonary artery pressure and the diameter of the inferior vena cava. Lung ultrasound analyses the B-lines defined as artefactual images resulting from contact between air in "alveoli" and water in "septa". It can estimate pulmonary congestion. The aim of the study is to evaluate the lung ultrasound using "8 sites" score accuracy for estimating fluid overload of patients before hemodialysis session.
- Conditions
- Lung Ultrasound, Hemodialysis Complication
- Being tested
- lung ultrasound
- Keywords
- Lung ultrasound, Hemodialysis Complication, hemodialysis ultrafiltration volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasoundOther
Subjects are enrolled during their usual session in the hemodialysis unit of the Amiens University Hospital. Before starting the hemodialysis, lung ultrasound according to the "8 sites" score and a measure of bioimpedance will be performed in dorsal decubitus. In a 2nd time, an echocardiography is realized. During haemodialysis session, biological analysis and clinical score will be assessed
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with fluid overload
Fluid overloaded are determined by both tecniques : estimated fluid overload and lung ultrasound measured fluid overload
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start9 Nov 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung UltrasoundStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132036
- Sponsor's protocol ID
- PI2021_843_0136
- Acronym
- EP8SH
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2021
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound Assessment of Fluid Overload in Haemodialysis Patients Using 8 Sites Score
- ClinicalTrials.gov ID
- NCT05132036
- Acronym / sponsor ID
- EP8SH / PI2021_843_0136
- Conditions
- Lung Ultrasound, Hemodialysis Complication
- Keywords
- Lung ultrasound, Hemodialysis Complication, hemodialysis ultrafiltration volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determination of the hemodialysis ultrafiltration volume is guided by the clinician's estimate of dry weight. A poor estimate of this dry weight may result in insufficient fluid depletion causing a state of volume overload, which may be associated with long-term left ventricular failure, high blood pressure and excess of mortality. The diagnosis of fluid overload in haemodialysis patient is routinely based on clinical examination which consists of cardiopulmonary auscultation and edema palpation of limb member. Clinical examination can be completed by paraclinical examinations, and bioimpedance is an objective tool that assess fluid overload state. This test provides an individualized hydration status and fluid overload based on normal extracellular volume considering body composition. Echocardiography allows an accurate assessment of blood volume status by simultaneous studying left ventricular filling pressures, systolic pulmonary artery pressure and the diameter of the inferior vena cava. Lung ultrasound analyses the B-lines defined as artefactual images resulting from contact between air in "alveoli" and water in "septa". It can estimate pulmonary congestion. The aim of the study is to evaluate the lung ultrasound using "8 sites" score accuracy for estimating fluid overload of patients before hemodialysis session.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age over 18 years old
- patients on hemodialysis for more than 3 months;
- patients without cardiological or infectious event for at least 3 months;
- patients having at least 2 dialysis session per week;
- patients affiliated with a health insurance plan;
Key exclusion criteria (6 listed)
- Pulmonary fibrosis or active lung disease;
- residual diuresis over 500 mL per day;
- body mass index (BMI) < 21 and > 28 Kg/m²;
- medical history of major amputation (subgonal or transfemoral);
- pacemaker carrier;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lung ultrasoundSubjects are enrolled during their usual session in the hemodialysis unit of the Amiens University Hospital. Before starting the hemodialysis, lung ultrasound according to the "8 sites" score and a measure of bioimpedance will be performed in dorsal decubitus. In a 2nd time, an echocardiography is realized. During haemodialysis session, biological analysis and clinical score will be assessed | Other | – |
Primary outcome
number of patients with fluid overload
Time frame: one day
Fluid overloaded are determined by both tecniques : estimated fluid overload and lung ultrasound measured fluid overload
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lung ultrasound in people with Lung Ultrasound and Hemodialysis Complication, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with fluid overload (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.