Venous CongestionNCT06440772
Portal Vein Pulsatility Index to Assess Fluid Intolerance
An observational study of Venous Congestion, run by Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu at 1 site in Romania.
Trial summary
This study uses the portal vein pulsatility index (PVPI) to assess fluid intolerance amongst fluid responders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Congestion
- What is being tested?
- Ringer's Lactate Crystalloid Solutions
- How many people
- 50 participants
- Where
- 1 siteRomania
- Study dates
- 1 May 2023to 1 Jul 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: Mechanically ventilated postoperative adult patients after cardiac surgery within 6 hours after intensive care unit admission.
Who may be able to join
- Informed consent.
- Mechanically ventilated patients within 6 hours after ICU admission following surgery who are considered for fluid administration to optimize haemodynamics.
- Sinus rhythm.
Who cannot join
- A condition known to interfere with portal vein flow assessment or interpretation (liver cirrhosis or chronic hepatic disease, suprahepatic or portal vein thrombosis).
- Any mechanical circulatory support.
- Cardiac transplant.
- Poor transthoracic echocardiographic window.
Trial locations and contacts
1 site in 1 country.
Romania1 site
"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
Bucharest, 022328
About this study
Official title: Assessing Fluid Intolerance Using Portal Vein Pulsatility Index Post-Passive Leg Raising Test in Fluid Responders: A Prospective Cohort Study
This study uses the portal vein pulsatility index (PVPI) to assess fluid intolerance amongst fluid responders.
Read the detailed description
This prospective observational study aims to use the portal vein pulsatility index (PVPI) to assess fluid intolerance in fluid responders. The investigators will enroll mechanically ventilated postoperative adult patients within 6 hours of ICU admission after cardiac surgery. Patients will undergo a Passive Leg Raising (PLR) test and Left Ventricular Outflow Tract (LVOT) recording using transthoracic echocardiography. The main objective is to predict fluid intolerance after a fluid challenge of 7 ml/kg Ringer Lactate over 10 minutes in initially tolerant fluid responders.
- Conditions
- Venous Congestion
- Being tested
- Ringer's Lactate Crystalloid Solutions
- Keywords
- congestion, portal vein pulsatility, ultrasound, fluid responsiveness, fluid tolerance
- Medical subject headings
- Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer's Lactate Crystalloid SolutionsDrug
Also called Fluid challenge
7 ml/kg ml of Ringer's Lactate is given in 10 min amongst initially tolerant fluid responders.
| Study group | Role | What they receive |
|---|---|---|
| Tolerant Fluid Responders | Patients who are both responsive and tolerant to fluid. Receives: Drug: Ringer's Lactate Crystalloid Solutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid Intolerance
A portal vein pulsatility index greater than 50%, calculated as (Vmax - Vmin) / Vmax, with no upper limit and 0% as the minimum limit. Higher values indicate worse outcomes. Ultrasonographic portal spectral waveform was used to measure Vmax and Vmin.
Measured: 10 minutes after 7 ml/kg Ringer's Lactate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 May 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Venous CongestionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balan Ion Cosmin, Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
- Investigators
- Cosmin Balan, PhD, Principal investigator, "Prof CC Iliescu" Emergency Institue for Cardiovascular DiseasesSerban-Ion Bubenek-Turconi, Professor, Study chair, "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440772
- Sponsor's protocol ID
- 6066/21.02.2023
- Status last verified
- Aug 2024
- First submitted
- 30 May 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Balan C, Morosanu B, Fodoroiu A, Dobre V, Dumitrache A, Barbulescu RT, Valeanu L, Robu C, Boros C, Nica A, Wong A, Corradi F, Grintescu IM, Bubenek-Turconi SI. Decoding portal vein pulsatility: hemodynamic determinants in a post-hoc analysis of a prospective observational trial. Ann Intensive Care. 2025 Jun 14;15(1):81. doi: 10.1186/s13613-025-01498-0.
PubMed 40515791Morosanu B, Balan C, Boros C, Dazzi F, Wong A, Corradi F, Bubenek-Turconi SI. Incidence, predictability, and outcomes of systemic venous congestion following a fluid challenge in initially fluid-tolerant preload-responders after cardiac surgery: a pilot trial. Crit Care. 2024 Oct 22;28(1):339. doi: 10.1186/s13054-024-05124-6.
PubMed 39439007
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Fluid Intolerance Using Portal Vein Pulsatility Index Post-Passive Leg Raising Test in Fluid Responders: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06440772
- Acronym / sponsor ID
- 6066/21.02.2023
- Conditions
- Venous Congestion
- Keywords
- congestion, portal vein pulsatility, ultrasound, fluid responsiveness, fluid tolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. IliescuUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 4 Jun 2024 (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.
This study uses the portal vein pulsatility index (PVPI) to assess fluid intolerance amongst fluid responders.
Detailed description
This prospective observational study aims to use the portal vein pulsatility index (PVPI) to assess fluid intolerance in fluid responders. The investigators will enroll mechanically ventilated postoperative adult patients within 6 hours of ICU admission after cardiac surgery. Patients will undergo a Passive Leg Raising (PLR) test and Left Ventricular Outflow Tract (LVOT) recording using transthoracic echocardiography. The main objective is to predict fluid intolerance after a fluid challenge of 7 ml/kg Ringer Lactate over 10 minutes in initially tolerant fluid responders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tolerant Fluid Responders | – | Drug: Ringer's Lactate Crystalloid SolutionsPatients who are both responsive and tolerant to fluid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated postoperative adult patients after cardiac surgery within 6 hours after intensive care unit admission.
Key inclusion criteria (3 listed)
- Informed consent.
- Mechanically ventilated patients within 6 hours after ICU admission following surgery who are considered for fluid administration to optimize haemodynamics.
- Sinus rhythm.
Key exclusion criteria (4 listed)
- A condition known to interfere with portal vein flow assessment or interpretation (liver cirrhosis or chronic hepatic disease, suprahepatic or portal vein thrombosis).
- Any mechanical circulatory support.
- Cardiac transplant.
- Poor transthoracic echocardiographic window.
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 |
|---|---|---|
| Ringer's Lactate Crystalloid SolutionsAlso: Fluid challenge7 ml/kg ml of Ringer's Lactate is given in 10 min amongst initially tolerant fluid responders. | Drug | Tolerant Fluid Responders |
Primary outcome
Fluid Intolerance
Time frame: 10 minutes after 7 ml/kg Ringer's Lactate
A portal vein pulsatility index greater than 50%, calculated as (Vmax - Vmin) / Vmax, with no upper limit and 0% as the minimum limit. Higher values indicate worse outcomes. Ultrasonographic portal spectral waveform was used to measure Vmax and Vmin.
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 27 Aug 2024.
- Derived from this study: PubMed 40515791Balan C, Morosanu B, Fodoroiu A, Dobre V, Dumitrache A, Barbulescu RT, Valeanu L, Robu C, Boros C, Nica A, Wong A, Corradi F, Grintescu IM, Bubenek-Turconi SI. Decoding portal vein pulsatility: hemodynamic determinants in a post-hoc analysis of a prospective observational trial. Ann Intensive Care. 2025 Jun 14;15(1):81. doi: 10.1186/s13613-025-01498-0.
- Derived from this study: PubMed 39439007Morosanu B, Balan C, Boros C, Dazzi F, Wong A, Corradi F, Bubenek-Turconi SI. Incidence, predictability, and outcomes of systemic venous congestion following a fluid challenge in initially fluid-tolerant preload-responders after cardiac surgery: a pilot trial. Crit Care. 2024 Oct 22;28(1):339. doi: 10.1186/s13054-024-05124-6.
Related trials for Venous Congestion
Recruiting
VEXUS-REA : Evaluation of Ultrasound Parameters of Venous Congestion in Patients in a Medical Intensive Care Unit
Venous Congestion
Not yet recruiting
Structured Hemodynamic Assessment to Guide Care After Cardiac Surgery
Cardiac Surgical Procedures, Hemodynamics
Active, not recruitingPhase 4
PVP-Guided Decongestive Therapy in HF 2
Heart Failure, Congestion
Not yet recruitingObservational study
Portal and Splenic Venous Pulsatility in Postoperative Critically Ill Patients
Venous Congestion, Postoperative Care
RecruitingObservational study
Evaluation of the Association Between the VEXUS Score and Hemodynamic Status and the Occurrence of Acute Kidney Injury After Open-Heart Surgery
Acute Kidney Injury After Open Heart Surgery, Venous Congestion After Open Heart Surgery
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.
Cosmin Balan, PhD principal investigator
"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
Serban-Ion Bubenek-Turconi, Professor study chair
"Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
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 Venous Congestion, run by Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu at 1 site in Romania.
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 3 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 27 Aug 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 Romania. 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?
Fluid Intolerance (time frame: 10 minutes after 7 ml/kg Ringer's Lactate). 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 NCT06440772, which also lists 2 linked publications.
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 27 Aug 2024.