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

11. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

2740

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
30-day mortality
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
90-day mortality
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: 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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. Oktober 2019

Primärer Abschluss (Tatsächlich)

1. Dezember 2022

Studienabschluss (Tatsächlich)

15. Dezember 2024

Studienanmeldedaten

Zuerst eingereicht

19. November 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Mai 2026

Zuerst gepostet (Tatsächlich)

15. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Mai 2026

Zuletzt verifiziert

1. November 2025

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • APHP240993
  • CSE 19-0019 (Andere Kennung: CSE)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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