Cardiovascular InsufficiencyFLUID-REVENGENCT05828407
Fluid Challenge Impact in the Portal Vein Pulsatility Depending on the Fluid Responsivness Status
An observational study of Cardiovascular Insufficiency and Venous Congestion, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Portal vein pulsatility index is a marker of venous congestion evaluated by point of care ultrasound. It is associated with acute kidney injury, especially in critically ill patients. It may be considered as a dynamic marker. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Insufficiency, Venous Congestion
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jul 2023to 3 Jun 2024
- Phase
- Observational
- 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
Study population: Adult intensive care patients with both grade 1 or higher venous congestion (VeXus C criteria) and acute circulatory failure.
Who may be able to join
- vasopressor requirement to maintain mean arterial pressure >65mmHg AND
- at least one of the following criteria:
- arterial lactate >2mmol/L;
- capillary refill time >3s;
- mottling score >1;
- diuresis <0,5mL/h for more than 6hours.
Who cannot join
- Diameter of vena cava <20mm
- Cirrhosis
- Pregnancy
- Severe acute pulmonary edema
- Phototype 4 or 5
- Patient opposition to participate
Trial locations and contacts
1 site in 1 country.
About this study
Portal vein pulsatility index is a marker of venous congestion evaluated by point of care ultrasound. It is associated with acute kidney injury, especially in critically ill patients. It may be considered as a dynamic marker. The investigators hypothesized that portal vein pulsatility index is higher after a fluid challenge only in patient without preload dependence in critically ill patients with cardiovascular insufficiency.
- Conditions
- Cardiovascular Insufficiency, Venous Congestion
- Keywords
- Point of care ultrasound, Portal vein pulsatility index, Venous congestion, Preload dependence
- Medical subject headings
- Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Population: Critically ill patient with: * cardio circulatory insufficiency as defined by vasopressor requirement and at least one of the following criteria: arterial lactate >2mmol/L ; capillary refill time >3s ; mottling score >1 ; diuresis <0,5mL/h for more than 6hours * diameter of inferior vena cava >20mm Protocol: Administration of a fluid challenge (4mL/kg of Ringer Lactate) over 5 to 10 min. Point of care ultrasound evaluation of portal vein pulsatility index and Vexus criteria before and after the fluid challenge ; fluid challenge induced cardiac index variations estimated by pulse contour analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Portal vein pulsatility index variation induced by the fluid challenge (%), defined by: Portal vein pulsatility index before the fluid challenge - portal vein pulsatility index after the fluid challenge.
Portal vein pulsatility index is defined as the (maximal velocity - minimal velocity) / maximal velocity assessed with doppler in portal vein estimated with point of care ultrasound.
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start10 Jul 2023
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular InsufficiencyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin RUSTE, MD, Principal investigator, Département d'anesthésie-réanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828407
- Sponsor's protocol ID
- 69HCL22_1115
- Other IDs
- 2023-A00196-39
- Acronym
- FLUID-REVENGE
- Status last verified
- Jun 2024
- First submitted
- 16 Mar 2023
- Last updated
- 7 Jun 2024
- 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 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Challenge Impact in the Portal Vein Pulsatility Depending on the Fluid Responsivness Status
- ClinicalTrials.gov ID
- NCT05828407
- Acronym / sponsor ID
- FLUID-REVENGE / 69HCL22_1115
- Conditions
- Cardiovascular Insufficiency, Venous Congestion
- Keywords
- Point of care ultrasound, Portal vein pulsatility index, Venous congestion, Preload dependence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 25 Apr 2023 (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.
Portal vein pulsatility index is a marker of venous congestion evaluated by point of care ultrasound. It is associated with acute kidney injury, especially in critically ill patients. It may be considered as a dynamic marker. The investigators hypothesized that portal vein pulsatility index is higher after a fluid challenge only in patient without preload dependence in critically ill patients with cardiovascular insufficiency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | –Population: Critically ill patient with: * cardio circulatory insufficiency as defined by vasopressor requirement and at least one of the following criteria: arterial lactate >2mmol/L ; capillary refill time >3s ; mottling score >1 ; diuresis <0,5mL/h for more than 6hours * diameter of inferior vena cava >20mm Protocol: Administration of a fluid challenge (4mL/kg of Ringer Lactate) over 5 to 10 min. Point of care ultrasound evaluation of portal vein pulsatility index and Vexus criteria before and after the fluid challenge ; fluid challenge induced cardiac index variations estimated by pulse contour analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult intensive care patients with both grade 1 or higher venous congestion (VeXus C criteria) and acute circulatory failure.
Key inclusion criteria (6 listed)
- vasopressor requirement to maintain mean arterial pressure >65mmHg AND
- at least one of the following criteria:
Key exclusion criteria (6 listed)
- Diameter of vena cava <20mm
- Cirrhosis
- Pregnancy
- Severe acute pulmonary edema
- Phototype 4 or 5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Portal vein pulsatility index variation induced by the fluid challenge (%), defined by: Portal vein pulsatility index before the fluid challenge - portal vein pulsatility index after the fluid challenge.
Time frame: One hour
Portal vein pulsatility index is defined as the (maximal velocity - minimal velocity) / maximal velocity assessed with doppler in portal vein estimated with point of care ultrasound.
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 7 Jun 2024.
- 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.
Martin RUSTE, MD principal investigator
Département d'anesthésie-réanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Insufficiency and Venous Congestion, run by Hospices Civils de Lyon 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 7 Jun 2024. 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 vein pulsatility index variation induced by the fluid challenge (%), defined by: Portal vein pulsatility index before the fluid challenge - portal vein pulsatility index after the fluid challenge. (time frame: One hour). 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 7 Jun 2024.