- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
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
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Paris, Frankreich, 75010
- Unité de Recherche Clinique Paris Saclay
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
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
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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30-day mortality
Zeitfenster: 30 days
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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
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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90-day mortality
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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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Mitarbeiter und Ermittler
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
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- APHP240993
- CSE 19-0019 (Andere Kennung: CSE)
Plan für individuelle Teilnehmerdaten (IPD)
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Studiendaten/Dokumente
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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