Serum in Sepsis and Septic Shock - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Biological: Serum

Detailed Description

Sepsis is a major cause of admission to intensive care units and is responsible for approximately 11 million deaths worldwide each year. It may be complicated by an acute brain dysfunction known as sepsis-associated encephalopathy (SAE), which affects about 50% of patients and typically manifests as delirium or coma. The diagnosis of SAE is primarily clinical, with EEG and brain MRI providing supportive information. Risk factors for SAE are mainly related to patient characteristics, including advanced age, chronic kidney disease, and pre-existing neurodegenerative or cognitive disorders. The pathophysiology of SAE involves three major mechanisms: neuroinflammation, endothelial dysfunction with blood-brain barrier disruption, and mitochondrial dysfunction leading to neuronal injury. These mechanisms likely explain both acute neurological symptoms and long-term psycho-cognitive sequelae. Following sepsis, 30-60% of patients develop psychiatric disorders and cognitive impairments comparable to those observed after moderate traumatic brain injury or early Alzheimer's disease. These sequelae are part of post-intensive care syndrome (PICS), supporting the need for structured post-ICU follow-up. However, the optimal target population and organization of such follow-up remain unclear, as some studies have reported reduced quality of life in patients receiving long-term follow-up. Identifying early biomarkers predictive of psycho-cognitive outcomes is therefore crucial, as current data on neuronal and glial biomarkers remain limited. Such biomarkers could improve prognostication, guide cognitive rehabilitation and psychological support, and contribute to the development of future neuroprotective strategies.

Primary objective:

To evaluate the value of biomarkers of brain injury for predicting cognitive impairment (memory impairment assessed by a MoCA score < 26/30) at 3 months.

Secondary objectives:

To evaluate the value of brain injury biomarkers for predicting delirium in the ICU, including hypoactive, hyperactive, and mixed phenotypes
To assess the association between brain injury biomarkers and the duration of delirium in the ICU
To evaluate the value of brain injury biomarkers for predicting psychological sequelae (anxiety, post-traumatic stress disorder, and depression) at 3 months
To evaluate the value of brain injury biomarkers for predicting functional neurological outcomes using the Glasgow Outcome Scale-Extended at ICU discharge and at 3 months
To assess the association between brain injury biomarkers and Post-Intensive Care Syndrome (PICS)
To assess the association between brain injury biomarkers and EEG abnormalities in the ICU
To assess the association between brain injury biomarkers and MRI abnormalities at 3 months

Study Type

Interventional

Enrollment (Estimated)

210

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Adèle BELLINO
Phone Number: +33 01 71 76 07 57
Email: adele.bellino@aphp.fr

Study Contact Backup

Name: Sarah BENGHANEM, Dr
Phone Number: +33 01 58 41 25 25
Email: sarah.benghanem@aphp.fr

Study Locations

France
- Île-de-France Region
  - Paris, Île-de-France Region, France, 75014
    - Hôpital Cochin - APHP Centre
    - Contact:
      
      Sarah BENGHANEM, Dr
      
      Phone Number: +33 01 58 41 25 25
      
      Email: sarah.benghanem@aphp.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Adults aged 18-80 years.
Admission to a medical or mixed ICU.
Sepsis or septic shock according to Sepsis-3 criteria.
ICU admission for less than 24 hours.
Need for invasive or non-invasive mechanical ventilation and/or vasopressor support.
Informed consent obtained from the patient or legal representative.

Exclusion Criteria:

Moribund patients.
Age >80 years.
Patients under legal guardianship.
History of schizophrenia or bipolar disorder.
Pregnancy.
No health insurance coverage.
Previous inclusion in the study.
Refusal to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function impairment assessed by the Montreal Cognitive Assessment (MoCA) score at 3 months Time Frame: 3 months	Montreal Cognitive Assessment (MoCA) ranges from 0 to 30 points, with higher scores indicating better cognitive performance. Cognitive impairment will be defined as a MoCA score <26/30.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coma- and/or delirium-free days Time Frame: Day 10 after inclusion		Day 10 after inclusion
Duration of delirium in the intensive care unit (ICU) Time Frame: 3 months		3 months
Type of ICU delirium: hypoactive, hyperactive, or mixed Time Frame: 3 months		3 months
Psychiatric disorders (anxiety, depression : ( 0 =min; 21 =max) , or PTSD) Time Frame: 3 months		3 months
Glasgow Outcome Scale-Extended (GOSE) Time Frame: 3 months		3 months
Delirium duration Time Frame: 3 months	Number of ICU days with delirium assessed using the Confusion Assessment Method for the ICU (CAM-ICU). Delirium duration will be reported as the cumulative number of ICU days with at least one positive CAM-ICU assessment. Higher values indicate longer delirium duration.	3 months
Delirium phenotype Time Frame: 3 months	ICU delirium phenotype classified as hypoactive, hyperactive or mixed according to CAM-ICU and RASS assessments. Results will be reported as the proportion of patients in each category.	3 months
Psychiatric outcomes Time Frame: 3 months	Symptoms of anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS; higher scores indicate greater symptom severity). PTSD assessed using the PTSD Checklist (PCL-5). Results will be reported as continuous scores and proportions of patients above validated thresholds	3 months
Functional outcome Time Frame: 3 months	Functional neurological outcome assessed using the Glasgow Outcome Scale-Extended (GOSE; range 1-8, higher scores indicate better functional recovery).	3 months
PICS : Post-Intensive Care Syndrome (PICS) Time Frame: 3 months	PICS is defined by the presence of cognitive impairment, psychiatric symptoms and/or physical disability at 3 months. Results will be reported as the proportion of patients fulfilling at least one PICS domain.	3 months
Neurological, psychiatric, or rehabilitation follow-up proposed to the patient Time Frame: 3 months	Referral for specialized follow-up after ICU discharge. This outcome will be reported as the proportion of patients referred to neurological consultation, psychiatric consultation, cognitive rehabilitation, physical rehabilitation and/or a multidisciplinary post-ICU clinic.	3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

ANR and Ministry of Health

Investigators

Principal Investigator: Sarah BENGHANEM, Dr, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

August 3, 2026

First Posted (Actual)

August 4, 2026

Study Record Updates

Last Update Posted (Actual)