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

NCT07591402 | Completed

• 2 other identifiers: APHP240993CSE 19-0019
• Study Type: observational
• Target: 2,740
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

D003924; D012139

Keywords

type 2 diabete; septic shock

Outcome Measures

Primary Outcomes (1)

• 30-day mortality

  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

Secondary Outcomes (5)

• 90-day mortality

  90 days after ICU admission.

• Multiorgan failures

  From ICU admission to ICU discharge (up to 30 days)

• Duration of vasopressor use

  From ICU admission to ICU discharge (up to 30 days)

• Mechanical ventilation

  From hospital admission to hospital discharge (up to 30 days)

• Acute Kidney Injury (AKI)

  From ICU admission to ICU discharge (up to 30 days)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with type 2 diabete
• admitted for septic shock to ICU (APHP) , from July 2017 to September 2022.

You may not qualify if:

• Patients under the age of 18,
• without electronical medical record,
• whithout any information about their antidiabetic treatment and those with multiple ICU hospitalization.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Unité de Recherche Clinique Paris Saclay

Paris, 75010, France

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: May 15, 2026
• Study Start: October 15, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 15, 2024
• Last Updated: May 15, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)