An observational study in Septic Shock, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
Among 30 studies in Shock, Septic by Assistance Publique - Hôpitaux de Paris — 15 open to participants now, 16 under way, 3 of them phase 3. Shock, Septic · Assistance Publique - Hôpitaux de Paris.
Among the 30 studies in Shock, Septic by Assistance Publique - Hôpitaux de Paris, this one is the 6th largest by planned enrollment of the 13 observational ones, is one of 6 that started in 2026, is one of 13 observational ones, reaches primary completion later than 11 of the 15 other live ones, and was the 25th registered.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 170 is above the median of 108 across 406 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →15 of the 30 studies in Shock, Septic by Assistance Publique - Hôpitaux de Paris are open now, in 1 country. Each count lists the studies.
Of the 136 Shock, Septic studies recruiting now, 102 (75%) set no upper age limit and 19 (14%) stop at 75 or younger; 12 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →30 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 6 started in 2026.
Median enrollment 210 across the 17 interventional studies, 110 across the 13 observational. Of the 11 that completed or were terminated, 0 (0%) have results posted.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
1 of the studies in Shock, Septic by Assistance Publique - Hôpitaux de Paris that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06851078Phase 3Assistance Publique - Hôpitaux de ParisEvaluation of Early Administration of Levetiracetam in the Prevention and Treatment Encephalopathy in Septic Shock: Randomized, Double-blind, Placebo-controlled Trial | 2027-06-15 |
Among the 30 studies in Shock, Septic by Assistance Publique - Hôpitaux de Paris, from their registry updates:
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.
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.
Patients with septic shock, defined according to proven or suspected infection with hypotension requiring vasopressor therapy, either community or hospital onset.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 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.
Time frame: at 48 hours
Day 28 mortality
Assessing the association between the 4 group classification mentionned above and day-28 mortality.
Time frame: 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.
Time frame: at 28 days
Start is estimated for Jun 2026; primary completion for Jun 2028, 24 months later.
Of 189 non-industry observational studies under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's planned 24 months is close to that.
Counting every sponsor, half of 202 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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