Hepatic Flow ChangesPORTEAUNCT03589261
Hepatic Blood Flow Changes During Fluid Challenge Assessed by MRI in Volunteers Subjects.
A study testing MRI (magnetic resonance imaging) in people with Hepatic Flow Changes, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Hepatic artery and portal flows are both regulated to assume the whole hepatic blood flow. Each counts for respectively 25% and 75%. That so-called "buffer response" assumes that when portal flow increases, hepatic artery flow decreases. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Flow Changes
- What is being tested?
- MRI (magnetic resonance imaging)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2018to 29 Mar 2019
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fasting for the last 12 hours.
Who cannot join
- Claustrophobia
- Any previous medical history disease;
- Any abdominal surgical disease
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hepatic Blood Flow Changes During Fluid Challenge Assessed by MRI in Volunteers Subjects: a Prospective Monocentric Study. PORTEAU Trial
Hepatic artery and portal flows are both regulated to assume the whole hepatic blood flow. Each counts for respectively 25% and 75%. That so-called "buffer response" assumes that when portal flow increases, hepatic artery flow decreases. During fluid challenge in intensive care unit, fluid challenge is often administered to improve hepatic perfusion. That observation is not demonstrated. The aim of the study is to test buffer response and portal flow during fluid challenge.
Read the detailed description
Prospective monocentric study at Amiens Hospital University. 20 volunteers subjects will be include after providing informed consent. Fluid challenge will be performed with 500 ml of intra venous NaCl (0.9%). Hepatic blood flow measurement will be performed using MRI.
- Conditions
- Hepatic Flow Changes
- Being tested
- MRI (magnetic resonance imaging)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI (magnetic resonance imaging)Device
Also called 500 ml of intra venous NaCl (0.9%).
Fluid challenge will be performed with 500 ml of intra venous NaCl (0.9%). Hepatic blood flow measurement will be performed using MRI.
| Study group | Role | What they receive |
|---|---|---|
| MRI (magnetic resonance imaging) | Other | Hepatic blood flow baseline will be measured using MRI. Fluid challenge of 500 ml of NaCl 0.9% will be administered during 10 minutes. Before and After fluid challenge, MRI will be performed to compare flow changes. Receives: Device: MRI (magnetic resonance imaging) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Portal blood flow measure before and after fluid challenge
Fluid challenge will be performed with 500 ml of intra venous NaCl (0.9%). Hepatic blood flow measurement will be performed using MRI (magnetic resonance imaging).
Measured: Two hours: the difference in hepatic portal flow before and after a volume expansion of 500 ml NaCl 0.9%.
Secondary outcomes (1)
Hepatic artery blood flow measure before and after fluid challenge
Hepatic artery blood flow measure before and after a volume expansion of 500 ml NaCl 0.9%.
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start6 Sep 2018
- Primary completion29 Mar 2019
- Study completion29 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic Flow ChangesStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT03589261
- Sponsor's protocol ID
- PI2018_843_0006
- Acronym
- PORTEAU
- Status last verified
- Sep 2025
- First submitted
- 3 Jul 2018
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abou-Arab O, Beyls C, Moussa MD, Huette P, Beaudelot E, Guilbart M, De Broca B, Yzet T, Dupont H, Bouzerar R, Mahjoub Y. Portal Vein Pulsatility Index as a Potential Risk of Venous Congestion Assessed by Magnetic Resonance Imaging: A Prospective Study on Healthy Volunteers. Front Physiol. 2022 Apr 29;13:811286. doi: 10.3389/fphys.2022.811286. eCollection 2022.
PubMed 35574483
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Blood Flow Changes During Fluid Challenge Assessed by MRI in Volunteers Subjects: a Prospective Monocentric Study. PORTEAU Trial
- ClinicalTrials.gov ID
- NCT03589261
- Acronym / sponsor ID
- PORTEAU / PI2018_843_0006
- Conditions
- Hepatic Flow Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 17 Jul 2018 (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.
Hepatic artery and portal flows are both regulated to assume the whole hepatic blood flow. Each counts for respectively 25% and 75%. That so-called "buffer response" assumes that when portal flow increases, hepatic artery flow decreases. During fluid challenge in intensive care unit, fluid challenge is often administered to improve hepatic perfusion. That observation is not demonstrated. The aim of the study is to test buffer response and portal flow during fluid challenge.
Detailed description
Prospective monocentric study at Amiens Hospital University. 20 volunteers subjects will be include after providing informed consent. Fluid challenge will be performed with 500 ml of intra venous NaCl (0.9%). Hepatic blood flow measurement will be performed using MRI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI (magnetic resonance imaging) | Other | Device: MRI (magnetic resonance imaging)Hepatic blood flow baseline will be measured using MRI. Fluid challenge of 500 ml of NaCl 0.9% will be administered during 10 minutes. Before and After fluid challenge, MRI will be performed to compare flow changes. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Fasting for the last 12 hours.
Key exclusion criteria (4 listed)
- Claustrophobia
- Any previous medical history disease;
- Any abdominal surgical disease
- Pregnancy or breastfeeding
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 |
|---|---|---|
| MRI (magnetic resonance imaging)Also: 500 ml of intra venous NaCl (0.9%).Fluid challenge will be performed with 500 ml of intra venous NaCl (0.9%). Hepatic blood flow measurement will be performed using MRI. | Device | MRI (magnetic resonance imaging) |
Primary outcome
Portal blood flow measure before and after fluid challenge
Time frame: Two hours: the difference in hepatic portal flow before and after a volume expansion of 500 ml NaCl 0.9%.
Fluid challenge will be performed with 500 ml of intra venous NaCl (0.9%). Hepatic blood flow measurement will be performed using MRI (magnetic resonance imaging).
1 secondary outcome
Hepatic artery blood flow measure before and after fluid challenge
Time frame: Two hours
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 Sep 2025.
- Results publication: PubMed 35574483Abou-Arab O, Beyls C, Moussa MD, Huette P, Beaudelot E, Guilbart M, De Broca B, Yzet T, Dupont H, Bouzerar R, Mahjoub Y. Portal Vein Pulsatility Index as a Potential Risk of Venous Congestion Assessed by Magnetic Resonance Imaging: A Prospective Study on Healthy Volunteers. Front Physiol. 2022 Apr 29;13:811286. doi: 10.3389/fphys.2022.811286. eCollection 2022.
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 MRI (magnetic resonance imaging) in people with Hepatic Flow Changes, 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 1 inclusion and 4 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 Sep 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?
Portal blood flow measure before and after fluid challenge (time frame: Two hours: the difference in hepatic portal flow before and after a volume expansion of 500 ml NaCl 0.9%.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03589261, which also lists 1 linked publication.
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 Sep 2025.