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Value of Biomarkers of Brain Injury for Predicting Psycho-cognitive Sequelae Secondary to Sepsis: a Prospective Multicenter Study (SEPSYM)

2026년 8월 3일 업데이트: Assistance Publique - Hôpitaux de Paris

To evaluate the value of biomarkers of neuronal and glial injury for predicting cognitive impairment (memory impairment assessed by a MoCA score < 26/30) at 3 months in patient admitted in the intensive care unit for a sepsis or a septic shock.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

생물학적: Serum

상세 설명

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

연구 유형

중재적

등록 (추정된)

210

단계

해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Adèle BELLINO
전화번호: +33 01 71 76 07 57
이메일: adele.bellino@aphp.fr

연구 연락처 백업

이름: Sarah BENGHANEM, Dr
전화번호: +33 01 58 41 25 25
이메일: sarah.benghanem@aphp.fr

연구 장소

프랑스
- Île-de-France Region
  - Paris, Île-de-France Region, 프랑스, 75014
    - Hôpital Cochin - APHP Centre
    - 연락하다:
      
      Sarah BENGHANEM, Dr
      
      전화번호: +33 01 58 41 25 25
      
      이메일: sarah.benghanem@aphp.fr

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 특수 증상
할당: 해당 없음
중재 모델: 단일 그룹 할당
마스킹: 없음(오픈 라벨)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Cognitive function impairment assessed by the Montreal Cognitive Assessment (MoCA) score at 3 months 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Coma- and/or delirium-free days 기간: Day 10 after inclusion		Day 10 after inclusion
Duration of delirium in the intensive care unit (ICU) 기간: 3 months		3 months
Type of ICU delirium: hypoactive, hyperactive, or mixed 기간: 3 months		3 months
Psychiatric disorders (anxiety, depression : ( 0 =min; 21 =max) , or PTSD) 기간: 3 months		3 months
Glasgow Outcome Scale-Extended (GOSE) 기간: 3 months		3 months
Delirium duration 기간: 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 기간: 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 기간: 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 기간: 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) 기간: 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 기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Assistance Publique - Hôpitaux de Paris

협력자

URC-CIC Paris Descartes Necker Cochin

ANR and Ministry of Health

수사관

수석 연구원: Sarah BENGHANEM, Dr, Assistance Publique - Hôpitaux de Paris

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2028년 5월 1일

연구 완료 (추정된)

2028년 8월 1일

연구 등록 날짜

최초 제출

2026년 3월 26일

QC 기준을 충족하는 최초 제출

2026년 8월 3일

처음 게시됨 (실제)

2026년 8월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)