- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07591402
Metformine as a Protective Factor of Mortality in Type 2 Diabetic Patients Admitted to the ICU for Septic Shock. (SEPSMET)
Metformine as a Protective Factor of Mortality in Type 2 Diabetic Patients Admitted to the ICU for Septic Shock: a Multicentre Retrospective Cohort Study.
연구 개요
상세 설명
Septic shock is one of the leading causes of admission to intensive care units (ICU), with an incidence of approximately 19 million patients per year worldwide. Despite progress made in the management of patients suffering from this condition, mortality and morbidity remain high and show little improvement. Indeed, according to studies, the mortality rate of septic shock ranges from 25 to 30%. Diabetic patients, due to their susceptibility to infections and greater vulnerability, represent a significant proportion of patient cohorts in septic shock. Moreover, diabetes is a factor of poor prognosis during septic shock.
Metformin, an oral anti-diabetic treatment, is currently considered the first-line therapy for type 2 diabetes. It modifies glucose metabolism by inhibiting, notably at the mitochondrial level, the electron transport chain through the inhibition of complex I. This inhibition of complex I decreases mitochondrial production of Adenosine Triphosphate (ATP) and induces activation of AMPK, a key enzyme in energy metabolism. Thus, metformin is responsible for an increase in glycolysis and an inhibition of gluconeogenesis in the liver.
During septic shock, mitochondrial ATP production is limited due to decreased arterial oxygen transport, leading to tissue hypoxia and mitochondrial dysfunction. This results in increased anaerobic energy production through activation of glycolysis, and consequently, increased lactate production responsible for metabolic acidosis. Several studies focusing on septic shock have observed that hyperlactatemia during the initial hours of management is a factor of poor prognosis.
Given the alterations in mitochondrial metabolism caused by metformin, which may exacerbate hyperlactatemia, its potential accumulation in cases of acute renal failure, the hepatic metabolism of lactate, and the deleterious consequences of lactic metabolic acidosis, it is recommended to discontinue metformin during septic shock. However, despite these recommendations, some studies suggest a lower mortality rate in septic shock patients treated with metformin, despite older age, higher rates of cardiovascular disease, and renal failure.
The first hypothesis is that patients on metformin may have better adaptation of their energy metabolism during a significant drop in oxygen supply (a mitochondrial adaptive mechanism reducing energy needs), which limits oxidative stress and its harmful effects. The second hypothesis is that metformin has an immunomodulatory role, resulting in a more moderate inflammatory response in case of infection, and thus less endothelial and visceral dysfunction. Thus, metformin, through modification of mitochondrial metabolism, appears to have pleiotropic, anti-inflammatory, antithrombotic, and vasoactive effects that could be beneficial in septic shock. The benefit of metformin in patients with septic shock therefore needs to be clarified through well-conducted large cohort studies.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Paris, 프랑스, 75010
- Unité de Recherche Clinique Paris Saclay
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients with type 2 diabete
- admitted for septic shock to ICU (APHP) , from July 2017 to September 2022.
Exclusion Criteria:
- Patients under the age of 18,
- without electronical medical record,
- whithout any information about their antidiabetic treatment and those with multiple ICU hospitalization.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
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Patients who receiving metformin before the inclusion
Patients with type 2 diabete admitted to ICU for septic shock who receiving metformin before the inclusion
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Patients who receiving other antidiabetic drugs before the inclusion
Patients with type 2 diabete admitted to ICU for septic shock who receiving other antidiabetic drugs before the inclusion
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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30-day mortality
기간: 30 days
|
The primary objective of this study is to evaluate the effect of metformin treatment on mortality in septic shock among type II diabetics patients. The primary endpoint is mortality within a 30-day time frame following admission to the intensive care unit. |
30 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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90-day mortality
기간: 90 days after ICU admission.
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Evaluate the effect of metformin treatment on mortality at 90 days after ICU admission.
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90 days after ICU admission.
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Multiorgan failures
기간: From ICU admission to ICU discharge (up to 30 days)
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Number of patients with at least one organ failure, defined by the presence of ≥1 ICD-10 diagnosis code for renal, hemodynamic, cardiac, respiratory, or hepatic failure.
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From ICU admission to ICU discharge (up to 30 days)
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Duration of vasopressor use
기간: From ICU admission to ICU discharge (up to 30 days)
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Duration of vasopressor use, defined as the cumulative number of days with administration of vasopressors based on repeated CCAM code EQLF003 (each code corresponding to 24 hours of therapy)
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From ICU admission to ICU discharge (up to 30 days)
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Mechanical ventilation
기간: From hospital admission to hospital discharge (up to 30 days)
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Number of patients with mechanical ventilation, defined by the presence of ≥1 CCAM procedure code for mechanical ventilation
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From hospital admission to hospital discharge (up to 30 days)
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Acute Kidney Injury (AKI)
기간: From ICU admission to ICU discharge (up to 30 days)
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Number of participants with acute kidney injury (AKI), defined according to the Kidney Disease Improving Global Outcomes (KDIGO)
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From ICU admission to ICU discharge (up to 30 days)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Marie Werner, MD, Service d'Anesthésie Réanimation Chirurgicale, DMU 12 Anesthésie Réanimation Chirurgicale Médecine Péri-opératoire et Douleur, Hôpital Bicêtre, AP-HP, Université Paris-Saclay, Le Kremlin-Bicêtre, France
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- APHP240993
- CSE 19-0019 (기타 식별자: CSE)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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