Evolution of Tissue Perfusion and Venous Congestion Markers in Fluid-Responsive Septic Shock Patients

NCT06958809 | Not Yet Recruiting

• 1 other identifier: 01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Septic shock remains a leading cause of mortality in intensive care, and while fluid resuscitation (FR) is a cornerstone of early management, its benefit-risk balance is highly variable. Excessive fluid administration can cause venous congestion and organ dysfunction, while insufficient resuscitation risks hypoperfusion. Current strategies often rely on fluid responsiveness (i.e., increased cardiac output after fluids), but this does not guarantee improved outcomes, particularly if congestion ensues. This prospective, multicenter, observational study aims to assess the clinical impact of FR in septic shock patients who are fluid responsive. The primary objective is to evaluate changes in tissue perfusion and venous congestion markers following FR. Patients will be categorized into four response profiles based on the presence or absence of perfusion improvement and congestion worsening. Secondary objectives include exploring the prognostic implications of each profile (organ dysfunction, mortality), identifying pre-FR predictors of adverse responses, evaluating changes in congestion markers after passive leg raising (PLR), and performing phenotypic clustering and mediation analyses. Eligible patients are adults with septic shock requiring vasopressors and mechanical ventilation, with confirmed fluid responsiveness via echocardiography. Each patient will undergo standardized pre- and post-FR assessments, including cardiac ultrasound, Doppler of hepatic/portal veins (VeXUS), CVP, perfusion markers, and blood gases. Data on SOFA scores, organ support duration, and 28-day mortality will be collected. Approximately 170 patients will be enrolled across five ICUs experienced in advanced hemodynamic monitoring. Statistical analyses will include multivariate modeling, clustering, ROC curves, and mediation analyses. By identifying phenotypes of fluid-responsive but fluid-intolerant patients, the study aims to refine fluid management strategies and improve outcomes through more personalized care in septic shock.

Conditions

Septic Shock; Fluid Resuscitation; Congestion, Venous

Keywords

septic shock; fluid resuscitation; venous congestion; tissue perfusion

Outcome Measures

Primary Outcomes (1)

• Comparison of septic shock patients based on a four-category classification based on 30 minutes to 1 hour after fluid resuscitation

  Comparison of septic shock patients based on a four-category classification

  30 minutes to 1 hour after fluid resuscitation

Secondary Outcomes (1)

• Evolution of the cardiovascular, respiratory, and renal SOFA scores at 24 hours after fluid resuscitation and on Day 28.

  24 hours after fluid resuscitation and on Day 28.

Interventions

Echography DIAGNOSTIC_TEST

An exhaustive echography will be performed to determine fluid responsiveness (using a passive leg raising test and cardiac output measurement by left ventricular outflow tract velocity time integral)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in septic shock, defined according to the Sepsis-3 criteria (7), who are under mechanical ventilation, have a central venous catheter in the superior vena cava territory and an arterial catheter, present with hypotension requiring vasopressor support and hyperlactatemia, and demonstrate a response to fluid resuscitation as per standard definition (i.e., an increase in cardiac output \>10% assessed by subaortic velocity time integral \[VTI\] using echocardiography).

You may qualify if:

• Septic shock (sepsis-3 criteria)
• Under mechanical ventilation
• Central venous catheter in the superior vena cava territory and arterial catheter in place
• Response to fluid resuscitation as per standard definition (i.e., an increase in cardiac output \>10% assessed by subaortic velocity time integral \[VTI\] using echocardiography)

You may not qualify if:

• Patient under 18 years of age
• Lack of social security coverage / adult under legal protection
• Pregnant woman
• Inability to obtain non-opposition consent

Sponsors & Collaborators

• Hospital Ambroise Paré Paris: lead

Study Sites (1)

Hôpital Ambroise Paré, Assistance Publique Hôpitaux de Paris,

Boulogne-Billancourt, 92100, France

Location

MeSH Terms

Conditions

Shock, Septic; Hyperemia

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Adrien JOSEPH, MD, PhD

CONTACT

+33149094409; adrien.joseph@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: May 6, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)