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임상시험 NCT07483710 (SIMS)은(는) 패혈성 쇼크에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Association Between Muscle L3 CT Scan Muscle Derived Parameters of Muscle Function Upon Intensive Care Unit Admission and 3 Months Mortality After ICU Discharge for Patients Admitted for Septic Shock. The SIMS Study 196
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07483710 (SIMS)은(는) 패혈성 쇼크에 대해 알아보는 중재연구입니다. 현재 상태는 대상자모집전이며, 2026년 4월 1일부터 참여 신청이 가능합니다. 196명의 참여자를 모집할 예정입니다. Centre Hospitalier Universitaire de Saint Etienne이(가) 진행하는 이 연구는 2030년 5월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 19일에 갱신되었습니다.
간단한 개요
Muscle dysfunction in intensive care units is associated with significant morbidity and mortality. During septic shock, there is an increased catabolism and systemic inflammation resulting in quantitative and qualitative muscle impairment. In the intensive care setting, quantitative and qualitative assessment of muscle function is challenging due to critical care environments (general anesthesia, altered consciousnes...더 보기
상세한 설명
To date, no prospective study has assessed the prognostic value of CT scan measurements of muscle function upon admission to intensive care units for patients treated for septic shock. That is the aim of this project.
공식 제목
Association Between Muscle L3 CT Scan Muscle Derived Parameters of Muscle Function Upon Intensive Care Unit Admission and 3 Months Mortality After ICU Discharge for Patients Admitted for Septic Shock. The SIMS Study
질환명
패혈성 쇼크기타 연구 식별자
- SIMS
- 25CH035
- ANSM (기타 식별자) (2025-A01160-49)
NCT 번호
실제 연구 시작일
2026-04-01
최신 업데이트 게시
2026-03-19
예상 연구 완료일
2030-05-01
계획된 등록 인원
196
연구종류
중재연구
단계/상
해당 없음
상태
대상자모집전
키워드
septic shock
CT Scan
CT Scan
주요 목적
기타
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
기타Septic shock patients Evaluation of muscle dysfunction in intensive care units for septic shock patients | Evaluation of muscle dysfunction in intensive care units for septic schock patients Correlation between muscle L3 CT scan muscle derived parameters of muscle function upon intensive care unit admission and 3 months mortality after ICU discharge for patients admitted for septic shock |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
vital status | alive or dead | 90 days |
Total muscle mass measured at L3 (cm²/m² ) | Total muscle mass measured at L3 by CT scan, normalized by patient height (Skeletal Muscle Index), in cm²/m² upon admission to the ICU (Correlation between three L3 CT scan parameters of muscle function upon admission to the intensive care unit and the risk of mortality at 3 months after ICU discharge in septic shock patients). | at inclusion |
Total muscle density measured at L3 ( Hounsfield Unit) | \- Total muscle density measured at L3 by CT scan (Skeletal Muscle Density) in HU upon admission to the ICU (Correlation between three L3 CT scan parameters of muscle function upon admission to the intensive care unit and the risk of mortality at 3 months after ICU discharge in septic shock patients). | at inclusion |
Total fat excretion fraction measured at L3 (%) | Total fat excretion fraction measured at L3 (Fat Fraction) by CT scan upon admission to the ICU (Correlation between three L3 CT scan parameters of muscle function upon admission to the intensive care unit and the risk of mortality at 3 months after ICU discharge in septic shock patients). | at inclusion |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
SOFA (Sequential Organ Failure Assessment) severity score | minimum=0, maximum=3 (Worse score) | at inclusion, 10 days. |
Kinetics of changes in muscle assessment | To assess the kinetics of changes in muscle scan parameters and muscle function. | Day 1, 10, 90 |
Total fat excretion fraction measured at L3 (%) | Evolution of the total fat excretion fraction measured at L3 (Fat Fraction) by CT scan at inclusion, 10 days and 90 days. | at inclusion, 10 days, 90 days |
Total muscle density measured at L3 ( Hounsfield Unit) | Evolution of total muscle density measured at L3 by CT scan (Skeletal Muscle Density) in HU upon inclusion, 10 days, 90 days | at inclusion, 10 days, 90 days |
Total muscle mass measured at L3 (cm²/m² ) | Evolution of the total muscle mass measured at L3 by CT scan, normalized by patient height (Skeletal Muscle Index), in cm²/m² upon inclusion, 10 days, 90 days. | at inclusion, 10 days, 90 days |
MRC score (Medical Research Council) | Minimum=0 (worse score), Maximum=5 | at discharge from intensive care, 90 days |
Handgrip test (Kg) | at discharge from intensive care, 90 days |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
Patients hospitalized in intensive care for septic shock defined by the presence of a documented or suspected infection, plasma lactate >2 mmol/L, and an increase in SOFA score of more than 2 points from baseline (Singer et al., 2016)
- Patients who underwent a non-contrast CT scan within 48 hours prior to admission and up to 24 hours after admission to intensive care
- Patients affiliated with or eligible for social security
- Patients with a neuromuscular disease prior to admission to intensive care.
- Pregnant women
- Patients under guardianship and/or conservatorship
- Refusal of consent.
Centre Hospitalier Universitaire de Saint Etienne연구 대표 연락처
연락처: Nory Elhadjene, MD, (0)4.77.82.97.43, [email protected]
3 1개국에 임상시험 장소
Hospices Civils de Lyon, Lyon, 69000, France
Céline GUICHON, MD, 연락처, (0)4 26 10 93 51, [email protected]
CELINE GUICHON, MD, 공동연구자
Clinique Mutualiste, Saint-Etienne, 42000, France
DUPONT GUILLAUME, MD, 연락처, (0)4 77 12 12 12, [email protected]
Centre Hospitalier Universitaire de Saint-Etienne, Saint-Etienne, 42055, France
NORY ELHADJENE, MD, 연락처, (0)4.77.82.97.43, [email protected]