Effect of Statin Therapy on Sepsis-related Mortality in Intensive Care Unit Patients

NCT06354452 | Completed

• 1 other identifier: HGG2024_01
• Study Type: observational
• Target: 59,578
• Locations: 1 country
• Sites: 1

Brief Summary

The average age of patients with sepsis has increased in recent years in parallel with the incidence of sepsis. Many of these patients are frail and require various medications for the treatment of their chronic diseases. Common treatments, including e.g. sarcopenic drugs (statins, sulphonylureas, methyglinides), antioxidants that prevent sarcopenia (allopurinol) or immunoregulators (corticosteroids) may influence the survival and functional prognosis of these patients. Knowing which drugs influence sepsis survival and to what degree patients who survive sepsis have functional deterioration and increased comorbidity and which modifiable factors limit this may be essential.

Conditions

Sepsis; Septic Shock

Keywords

Sepsis; Mortality; Statins; Corticoid

Outcome Measures

Primary Outcomes (1)

• Death due to sepsis

  Inhospital death after an episode of sepsis requiring hospital or ICU admission

  From date of hospital admission until the date of hospital discharge, assessed up to 12 months

Study Arms (1)

Patients with a diagnosis of sepsis

All patients with a diagnosis of sepsis admitted to the hospitals of the public hospital network of Catalonia, Spain, were included.

Other: Person-level linkage of the database looking for relationship with sepsis survival and previous intake of certain drug families and previous dependence on health services.

Interventions

Person-level linkage of the database looking for relationship with sepsis survival and previous intake of certain drug families and previous dependence on health services. OTHER

A descriptive analysis of the baseline demographics, risk factors, health status, comorbidities, frailty, and previous dependence on health services of all patients admitted to hospitals in the region will be carried out. Both the overall data of patients admitted to hospitals in any ward and those admitted to ICU will be analysed. The survival data of patients will be compared with their previous individual drug consumption, trying to find out the relationship between chronic consumption of certain families of drugs and inhospital survival to sepsis. In addition, drug dependence and dependence on health services of sepsis survivors will be studied in comparison with their situation prior to sepsis.

Patients with a diagnosis of sepsis

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

All patients with a diagnosis of sepsis admitted to the hospitals of the public hospital network of Catalonia, Spain, will be included. The data will be obtained from the Catalan Health System (CatSalut) Minimum Basic Data Set (CMBD) registers (compulsory admissions register for all public and private acute care hospitals in Catalonia, Spain, over a 2-year period (2018 and 2019).

You may qualify if:

• Patients with a diagnosis of sepsis admitted to the hospitals of the public hospital network of Catalonia, Spain. Sepsis will be defined using the methodology described by Angus et al., which is currently referenced for population-based studies, consisting of coding a diagnosis of infection with acute organ failure, or sepsis or septic shock.

You may not qualify if:

• None

Sponsors & Collaborators

• Hospital de Granollers: lead
• Department of Health, Generalitat de Catalunya: collaborator

Study Sites (1)

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

Location

Related Publications (2)

• Iglesias R, Badia JM, Vela E, Yebenes JC. Baseline morbidity and chronic medications as determinants of sepsis outcomes: focus on statins, corticosteroids, and NSAIDs in a population-based cohort of 59,578 patients. Front Pharmacol. 2026 Jan 15;16:1727662. doi: 10.3389/fphar.2025.1727662. eCollection 2025.

  PMID: 41625328 DERIVED

• Iglesias R, Badia JM, Vela E, Monterde D, Carlos Yebenes J. Influence of comorbidities and chronic medications on ICU mortality in sepsis: A population-based cohort study of 12,095 patients. Med Clin (Barc). 2026 Jan 7;166(1):107265. doi: 10.1016/j.medcli.2025.107265. Online ahead of print. English, Spanish.

  PMID: 41505944 DERIVED

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Association

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychotherapeutic Processes; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Josep M Badia, MD, PhD

  Hospital General de Granollers

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: April 9, 2024
• Study Start: January 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)