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Metformine as a Protective Factor of Mortality in Type 2 Diabetic Patients Admitted to the ICU for Septic Shock. (SEPSMET)

2026년 5월 11일 업데이트: Assistance Publique - Hôpitaux de Paris

Metformine as a Protective Factor of Mortality in Type 2 Diabetic Patients Admitted to the ICU for Septic Shock: a Multicentre Retrospective Cohort Study.

Septic shock is a major complication of sepsis and is one of the leading causes of admission to intensive care unit (ICU) as well as a major contributor to global mortality, accounting for one in five deaths worldwide and approximately 11 million deaths annually. There is around 530 millions of people living with diabetes, with type 2 diabetes accounting for 96% of these population. Among these patients, septic shock is a major concern, as they are more susceptible to developing infections and have more associated comorbidities. Metformin is the first line oral treatment for type 2 diabete. Beyond its metabolic effects, metformin has pleitropic effects exerting actions on mitochondrial metabolism and immune-inflammatory pathway that could potentially be benefit in septic shock. Several observational studies, converge on a reduction in mortality among patients treated with long-term metformin prior to their admission to the ICU for sepsis or septic shock as well as a reduction in renal dysfunction. Despite these results, the current literature remains highly heterogeneous in its methodology. Most studies focused on patients with sepsis rather than targetting specifically most severe patients with septic shock. Study designs vary widely, most of them are monocentric, some included patients in the emergency departments and others compared type 2 diabetic patients to patients without any history of diabetes making comparisons and generalisation of findings difficult. The main objective of this study was to evaluate the effect of pre-admission metformin exposure in type 2 diabetic patients admitted to the ICU for septic shock on 30-day mortality and on organ failures.

연구 개요

상태

완전한

정황

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

관찰

등록 (실제)

2740

연락처 및 위치

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연구 장소

      • Paris, 프랑스, 75010
        • Unité de Recherche Clinique Paris Saclay

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

샘플링 방법

비확률 샘플

연구 인구

Adults patients with type 2 diabete admitted for septic shock to one of the 30 ICU across18 parisians hospitals (APHP) , from July 2017 to September 2022

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

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

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
Patients who receiving metformin before the inclusion
Patients with type 2 diabete admitted to ICU for septic shock who receiving metformin before the inclusion
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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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
90-day mortality
기간: 90 days after ICU admission.
Evaluate the effect of metformin treatment on mortality at 90 days after ICU admission.
90 days after ICU admission.
Multiorgan failures
기간: From ICU admission to ICU discharge (up to 30 days)
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.
From ICU admission to ICU discharge (up to 30 days)
Duration of vasopressor use
기간: From ICU admission to ICU discharge (up to 30 days)
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)
From ICU admission to ICU discharge (up to 30 days)
Mechanical ventilation
기간: From hospital admission to hospital discharge (up to 30 days)
Number of patients with mechanical ventilation, defined by the presence of ≥1 CCAM procedure code for mechanical ventilation
From hospital admission to hospital discharge (up to 30 days)
Acute Kidney Injury (AKI)
기간: From ICU admission to ICU discharge (up to 30 days)
Number of participants with acute kidney injury (AKI), defined according to the Kidney Disease Improving Global Outcomes (KDIGO)
From ICU admission to ICU discharge (up to 30 days)

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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

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 (실제)

2019년 10월 15일

기본 완료 (실제)

2022년 12월 1일

연구 완료 (실제)

2024년 12월 15일

연구 등록 날짜

최초 제출

2025년 11월 19일

QC 기준을 충족하는 최초 제출

2026년 5월 11일

처음 게시됨 (실제)

2026년 5월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 15일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 11일

마지막으로 확인됨

2025년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • APHP240993
  • CSE 19-0019 (기타 식별자: CSE)

개별 참가자 데이터(IPD) 계획

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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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