Septic ShockFLUID-IMPACTSNCT07685002
Characterizing Perfusion and Congestion Responses to Fluid Loading in Critically Ill Septic Patients
An observational study of Septic Shock, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Sepsis is a leading cause of mortality worldwide and a major contributor to deaths in intensive care units. Early hemodynamic resuscitation, particularly fluid loading, is a cornerstone of septic shock management. However, the benefit-risk balance of fluid administration is difficult to assess in routine practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2026to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with septic shock, defined according to proven or suspected infection with hypotension requiring vasopressor therapy, either community or hospital onset.
Who may be able to join
- Patients with septic shock, defined according to proven or suspected infection with hypotension requiring vasopressor therapy, either community or hospital onset.
- Mechanical ventilation
- Central venous catheter in the superior vena cava territory
- Arterial catheter in place
- Positive passive leg-raising (PLR) test-defined as an increase of >10% in subaortic velocity-time integral-which predicts responsiveness to fluid loading.
Who cannot join
- Contraindication to performing a passive leg-raising manoeuvre (e.g., unstable spinal fracture, intracranial hypertension, critical limb ischemia).
- Age < 18 years.
- Lack of social coverage or individuals deprived of liberty.
- Pregnant women.
- Extracorporeal membrane oxygenation (veno-venous or venoarterial)
- Cirrhosis with portal hypertension or portal vein thrombosis
- Inability to obtain non-opposition from the patient or their legal representative.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Sepsis is a leading cause of mortality worldwide and a major contributor to deaths in intensive care units. Early hemodynamic resuscitation, particularly fluid loading, is a cornerstone of septic shock management. However, the benefit-risk balance of fluid administration is difficult to assess in routine practice. Insufficient fluid resuscitation may result in persistent tissue hypoperfusion, organ ischemia, and multiorgan failure, whereas excessive fluid administration is associated with increased mortality, mainly due to systemic venous congestion and organ edema.
The concept of fluid tolerance, defined as the ability of a patient to receive fluids without developing harmful consequences related to fluid overload, is increasingly recognized. Nevertheless, its evaluation remains challenging because of the lack of validated tools and consensual thresholds. In addition, although several markers of tissue perfusion and systemic venous congestion have been described, their combined clinical relevance and prognostic value following fluid loading in septic shock have not been specifically evaluated.
Read more
This study aims to assess perfusion and congestion responses to fluid loading in patients with septic shock. The primary objective is to compare patients according to changes in tissue perfusion markers (lactate concentration, mottling score, capillary refill time, venous-to-arterial CO₂ gradient, and central venous oxygen saturation) and systemic venous congestion markers (central venous pressure and hepatic and portal vein Doppler indices) after fluid administration. Secondary objectives include evaluating the evolution of venous congestion markers and their association with organ dysfunction within 48 hours, the relationship between post-fluid loading congestion dynamics and 28-day mortality, and identifying pre-fluid loading predictors of patients who fail to improve tissue perfusion while exhibiting worsening venous congestion.
This is a prospective, multicenter, non-interventional observational cohort study conducted in five intensive care units. Eligible patients are adult patients with septic shock, mechanically ventilated, equipped with arterial and central venous catheters, and presenting a positive passive leg-raising test defined as an increase greater than 10% in cardiac output or left ventricular outflow tract velocity-time integral. All patients receive standard care in accordance with international guidelines, and fluid administration is entirely at the discretion of the treating physician.
Clinical, biological, hemodynamic, and echocardiographic data are collected before and after fluid loading. Patients are retrospectively classified into four groups based on the presence or absence of improvement in tissue perfusion and worsening of venous congestion. Follow-up continues until ICU discharge or day 28.
Approximately 280 patients are expected to be screened to include 170 patients. The results may help identify patients who are fluid responsive in terms of cardiac output but at risk of harmful venous congestion, supporting more individualized fluid resuscitation strategies in septic shock.
Read the detailed description
All patients receive standard care in accordance with current international guidelines. The decision to administer fluids, the type of crystalloid, and the infused volume are at the discretion of the treating physician.
Study data are collected at predefined time points before and after fluid resuscitation and include routinely measured clinical, biological, and hemodynamic parameters, as well as echocardiographic Doppler indices of systemic venous congestion. Patients are retrospectively classified into four groups according to the presence or absence of improvement in tissue perfusion markers and worsening of venous congestion markers. Follow-up continues until ICU discharge or day 28, with collection of organ dysfunction scores, fluid balance, and mortality data.
Based on previous data, approximately 280 patients are expected to be screened to include 170 patients, allowing meaningful comparisons across groups. The inclusion period is 23 months, with a 28-day follow-up and a total study duration of 24 months. Statistical analyses will compare groups using appropriate parametric or nonparametric tests, survival analysis using Cox proportional hazards models, and predictive modeling assessed by ROC curve analysis.
- Conditions
- Septic Shock
- Keywords
- sepsis, septic, shock, fluid load, organ dysfunction
- Medical subject headings
- Shock, Septic, Sepsis, Shock
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient classification 1 hour after completion of fluid loading
The primary objective of the study is to determine the proportion of patients belonging to the four categories defined by changes in tissue perfusion markers and systemic venous congestion markers, one hour after fluid load.
Group 1 : Improvement in tissue perfusion markers with no worsening of systemic venous congestion markers Group 2 : Improvement in tissue perfusion markers with worsening of systemic venous congestion markers Group 3 : No improvement in tissue perfusion markers with no worsening of systemic venous congestion markers Group 4 : No improvement in tissue perfusion markers with worsening of systemic venous congestion markers
Tissue perfusion will be assessed using blood lactate concentration, central venous oxygen saturation, venous-to-arterial carbon dioxide difference, mottling score and capillary refill time.
Systemic venous congestion will be assessed using portal vein pulsatility, hepatic vein doppler S/D ratio and central venous pressure.
Measured: at 1 hour
Change in SOFA score from baseline to 48 hours after fluid loading
Assessing the association between the 4 group classification mentionned above and organ dysfunction (defined as a increase in SOFA score components) within the 48 hours following fluid administration.
Measured: at 48 hours
Secondary outcomes (2)
Day 28 mortality
Assessing the association between the 4 group classification mentionned above and day-28 mortality.
Measured: at 28 days
Identifying pre-fluid loading predictors
Identifying pre-fluid loading predictors of belonging to the subgroup of patients who fail to show improvement in tissue perfusion and who demonstrate worsening systemic venous congestion.
Measured: at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685002
- Sponsor's protocol ID
- 24AJH-FLUID-IMPACTS
- Acronym
- FLUID-IMPACTS
- Status last verified
- Jun 2026
- First submitted
- 22 Jan 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Perfusion and Congestion Responses to Fluid Loading in Critically Ill Septic Patients
- ClinicalTrials.gov ID
- NCT07685002
- Acronym / sponsor ID
- FLUID-IMPACTS / 24AJH-FLUID-IMPACTS
- Conditions
- Septic Shock
- Keywords
- sepsis, septic, shock, fluid load, organ dysfunction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 6 Jul 2026 (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.
Sepsis is a leading cause of mortality worldwide and a major contributor to deaths in intensive care units. Early hemodynamic resuscitation, particularly fluid loading, is a cornerstone of septic shock management. However, the benefit-risk balance of fluid administration is difficult to assess in routine practice. Insufficient fluid resuscitation may result in persistent tissue hypoperfusion, organ ischemia, and multiorgan failure, whereas excessive fluid administration is associated with increased mortality, mainly due to systemic venous congestion and organ edema.
The concept of fluid tolerance, defined as the ability of a patient to receive fluids without developing harmful consequences related to fluid overload, is increasingly recognized. Nevertheless, its evaluation remains challenging because of the lack of validated tools and consensual thresholds. In addition, although several markers of tissue perfusion and systemic venous congestion have been described, their combined clinical relevance and prognostic value following fluid loading in septic shock have not been specifically evaluated.
This study aims to assess perfusion and congestion responses to fluid loading in patients with septic shock. The primary objective is to compare patients according to changes in tissue perfusion markers (lactate concentration, mottling score, capillary refill time, venous-to-arterial CO₂ gradient, and central venous oxygen saturation) and systemic venous congestion markers (central venous pressure and hepatic and portal vein Doppler indices) after fluid administration. Secondary objectives include evaluating the evolution of venous congestion markers and their association with organ dysfunction within 48 hours, the relationship between post-fluid loading congestion dynamics and 28-day mortality, and identifying pre-fluid loading predictors of patients who fail to improve tissue perfusion while exhibiting worsening venous congestion.
This is a prospective, multicenter, non-interventional observational cohort study conducted in five intensive care units. Eligible patients are adult patients with septic shock, mechanically ventilated, equipped with arterial and central venous catheters, and presenting a positive passive leg-raising test defined as an increase greater than 10% in cardiac output or left ventricular outflow tract velocity-time integral. All patients receive standard care in accordance with international guidelines, and fluid administration is entirely at the discretion of the treating physician.
Clinical, biological, hemodynamic, and echocardiographic data are collected before and after fluid loading. Patients are retrospectively classified into four groups based on the presence or absence of improvement in tissue perfusion and worsening of venous congestion. Follow-up continues until ICU discharge or day 28.
Approximately 280 patients are expected to be screened to include 170 patients. The results may help identify patients who are fluid responsive in terms of cardiac output but at risk of harmful venous congestion, supporting more individualized fluid resuscitation strategies in septic shock.
Detailed description
All patients receive standard care in accordance with current international guidelines. The decision to administer fluids, the type of crystalloid, and the infused volume are at the discretion of the treating physician.
Study data are collected at predefined time points before and after fluid resuscitation and include routinely measured clinical, biological, and hemodynamic parameters, as well as echocardiographic Doppler indices of systemic venous congestion. Patients are retrospectively classified into four groups according to the presence or absence of improvement in tissue perfusion markers and worsening of venous congestion markers. Follow-up continues until ICU discharge or day 28, with collection of organ dysfunction scores, fluid balance, and mortality data.
Based on previous data, approximately 280 patients are expected to be screened to include 170 patients, allowing meaningful comparisons across groups. The inclusion period is 23 months, with a 28-day follow-up and a total study duration of 24 months. Statistical analyses will compare groups using appropriate parametric or nonparametric tests, survival analysis using Cox proportional hazards models, and predictive modeling assessed by ROC curve analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with septic shock, defined according to proven or suspected infection with hypotension requiring vasopressor therapy, either community or hospital onset.
Key inclusion criteria (5 listed)
- Patients with septic shock, defined according to proven or suspected infection with hypotension requiring vasopressor therapy, either community or hospital onset.
- Mechanical ventilation
- Central venous catheter in the superior vena cava territory
- Arterial catheter in place
- Positive passive leg-raising (PLR) test-defined as an increase of >10% in subaortic velocity-time integral-which predicts responsiveness to fluid loading.
Key exclusion criteria (7 listed)
- Contraindication to performing a passive leg-raising manoeuvre (e.g., unstable spinal fracture, intracranial hypertension, critical limb ischemia).
- Age < 18 years.
- Lack of social coverage or individuals deprived of liberty.
- Pregnant women.
- Extracorporeal membrane oxygenation (veno-venous or venoarterial)
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
Patient classification 1 hour after completion of fluid loading
Time frame: at 1 hour
The primary objective of the study is to determine the proportion of patients belonging to the four categories defined by changes in tissue perfusion markers and systemic venous congestion markers, one hour after fluid load. Group 1 : Improvement in tissue perfusion markers with no worsening of systemic venous congestion markers Group 2 : Improvement in tissue perfusion markers with worsening of systemic venous congestion markers Group 3 : No improvement in tissue perfusion markers with no worsening of systemic venous congestion markers Group 4 : No improvement in tissue perfusion markers with worsening of systemic venous congestion markers Tissue perfusion will be assessed using blood lactate concentration, central venous oxygen saturation, venous-to-arterial carbon dioxide difference, mottling score and capillary refill time. Systemic venous congestion will be assessed using portal vein pulsatility, hepatic vein doppler S/D ratio and central venous pressure.
Change in SOFA score from baseline to 48 hours after fluid loading
Time frame: at 48 hours
Assessing the association between the 4 group classification mentionned above and organ dysfunction (defined as a increase in SOFA score components) within the 48 hours following fluid administration.
2 secondary outcomes
Day 28 mortality
Time frame: at 28 days
Identifying pre-fluid loading predictors
Time frame: at 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
Related trials for Septic Shock
Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
RecruitingObservational study
Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
Sepsis
RecruitingObservational study
Comparison of Cardiac Index Measurement Using Right Ventricular Pressure Curve Analysis and Thermodilution Via a Swan-Ganz IQ™ Catheter.
Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
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.
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 Septic Shock, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 6 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrien JOSEPH, MD, PhD (+33 1 49 09 44 09, adrien.joseph@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient classification 1 hour after completion of fluid loading (time frame: at 1 hour). The study lists 2 primary outcomes in all. 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 6 Jul 2026.