Population-Based Analysis of Incidence and Mortality of Septic Shock

NCT07174765 | Active Not Recruiting

• 1 other identifier: RADAR-Septic Shock Project
• Study Type: observational
• Target: 31,480
• Locations: 1 country
• Sites: 1

Brief Summary

RADAR-Septic Shock is a population-based observational study in Catalonia (Spain) that will identify all hospital discharges with septic shock between 2018 and 2023 using an audited population-based registry. The project will quantify incidence, describe patient characteristics and resource use, and compare risk-adjusted in-hospital mortality across hospitals to support quality improvement. Cases are defined by ICD-10 codes for septic shock (R65.21) and post-procedural septic shock (T81.12XA). In preliminary cohort counts, \>31,000 episodes were identified across 2018-2023; in 2023 the incidence was \~78 per 100,000 inhabitants with an overall in-hospital mortality of \~33%, higher in hospital-acquired than community-acquired episodes

Conditions

Septic Shock

Keywords

Sepsis; Septic shock

Outcome Measures

Primary Outcomes (1)

• Death due to septic shock

  Inhospital death after an episode of septic shock 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 septic shock

All patients with a diagnosis of septic shock discharged hospitals of the public hospital network of Catalonia, Spain, were included.

Other: Person-level linkage of the database looking for relationship with septic shock survival and comorbidities, previous intake of medication, and previous dependence on health services.

Interventions

Person-level linkage of the database looking for relationship with septic shock survival and comorbidities, previous intake of medication, 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 with septic shock to hospitals in the region will be carried out. The overall data of patients admitted to hospitals will be analysed. The survival data of patients will be compared with their previous individual drug consumption and inhospital survival to septic shock. In addition, drug dependence and dependence on health services of survivors will be studied in comparison with their situation prior to sepsis. The objective is to establish the Registry of Administrative Data Automatically Recorded for Septic Shock (RADAR-Septic Shock), leveraging administrative data to characterize septic shock incidence, describe patient profiles, identify population-specific healthcare needs, and provide benchmark values for performance assessment in Catalonia's public health system.

Patients with a diagnosis of septic shock

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 septic shockadmitted 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 6-year period (2018 and 2023).

You may qualify if:

• Patients with a diagnosis of septic shock admitted to the hospitals of the public hospital network of Catalonia, Spain. Septic shock 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

Study Sites (1)

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

Location

MeSH Terms

Conditions

Shock, Septic; Sepsis

Interventions

Association; Comorbidity

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; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

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: September 9, 2025
• First Posted: September 16, 2025
• Study Start: January 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: November 30, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)