Septic ShockRADARNCT07174765
Population-Based Analysis of Incidence and Mortality of Septic Shock
An observational study of Septic Shock, run by Hospital de Granollers at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- 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.
- How many people
- 31,480 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2018to 30 Nov 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Population-Based Analysis of Incidence and Mortality of Septic Shock: The Registry of Administrative Data Automatically Recorded-Septic Shock Project
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
Read the detailed description
Septic shock is the most severe manifestation of sepsis and remains a leading cause of death and healthcare utilisation. Outcomes vary by patient mix (age, comorbidities), acquisition setting, infection source, and hospital performance, underscoring the need for robust, population-level surveillance to guide policy and care pathways. RADAR-Septic Shock leverages routinely collected administrative data to provide standardised measures of incidence, resource use, and outcomes across an entire regional health system.
The study aims to quantify the population incidence of septic shock and describe patient demographics, comorbidity burden, infection sources, organ failures, and use of life-support therapies; 2) estimate in-hospital and short-term mortality and length of stay; and 3) benchmark hospitals using risk-adjusted observed-to-expected (O/E) mortality to identify variation and inform improvement strategies.
It is a population-based cohort using the Catalan Minimum Basic Data Set for Acute Care Hospitals (CMBD-HA), an audited, mandatory discharge registry covering all acute-care hospitals in the public system. The analytic period spans January 2018-December 2023.
It will include all hospital discharges containing a primary or secondary diagnosis code for septic shock (ICD-10-CM R65.21) or post-procedural septic shock (T81.12XA). This definition prioritises specificity and uniformity across centres. Episodes will be stratified by acquisition setting (community- vs hospital-acquired).
Extracted variables include: demographics (age, sex); comorbidities and morbidity burden (Adjusted Morbidity Groups [GMA] index); infection source; organ failures; advanced life-support interventions (mechanical ventilation, renal replacement therapy, ECMO); ICU admission; length of stay; and mortality.
Primary outcome: in-hospital mortality. Secondary outcomes: 30-day mortality (where available), ICU admission, length of stay, and use of life-support therapies. Preliminary registry summaries show >31,000 episodes across 2018-2023 and, for 2023, an incidence of ~78 per 100,000 with in-hospital mortality ~33% overall (higher in hospital-acquired episodes). These figures motivate the benchmarking component.
Descriptive statistics will summarise case mix and care processes, including incidence rates per 100,000 inhabitants. Multivariable logistic regression will estimate individual mortality risk; model performance will be assessed (e.g., AUROC) and used to generate expected mortality for each hospital. Comparative performance will be reported via O/E mortality ratios with confidence intervals. Length of stay will be modelled after appropriate transformation. Sensitivity analyses will explore the impact of acquisition setting, infection source, organ failures, and comorbidity burden.
Based on audited counts, the registry includes 31,480 septic shock episodes over 2018-2023 (6,182 in 2023), ensuring sufficient precision for risk modelling and hospital-level benchmarking across the regional network.
- Conditions
- Septic Shock
- Being tested
- 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.
- Keywords
- Sepsis, Septic shock
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death due to septic shock
Inhospital death after an episode of septic shock requiring hospital or ICU admission
Measured: From date of hospital admission until the date of hospital discharge, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Jan 2018
- Primary completion31 Dec 2023
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 31,480 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep M Badia, Hospital de Granollers
- Investigators
- Josep M Badia, MD, PhD, Study director, Hospital General de Granollers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174765
- Sponsor's protocol ID
- RADAR-Septic Shock Project
- Acronym
- RADAR
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Restrictions apply to the availability of these data, which belong to a national database and is not publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population-Based Analysis of Incidence and Mortality of Septic Shock: The Registry of Administrative Data Automatically Recorded-Septic Shock Project
- ClinicalTrials.gov ID
- NCT07174765
- Acronym / sponsor ID
- RADAR / RADAR-Septic Shock Project
- Conditions
- Septic Shock
- Keywords
- Sepsis, Septic shock
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 31,480 participants (actual)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Septic shock is the most severe manifestation of sepsis and remains a leading cause of death and healthcare utilisation. Outcomes vary by patient mix (age, comorbidities), acquisition setting, infection source, and hospital performance, underscoring the need for robust, population-level surveillance to guide policy and care pathways. RADAR-Septic Shock leverages routinely collected administrative data to provide standardised measures of incidence, resource use, and outcomes across an entire regional health system.
The study aims to quantify the population incidence of septic shock and describe patient demographics, comorbidity burden, infection sources, organ failures, and use of life-support therapies; 2) estimate in-hospital and short-term mortality and length of stay; and 3) benchmark hospitals using risk-adjusted observed-to-expected (O/E) mortality to identify variation and inform improvement strategies.
It is a population-based cohort using the Catalan Minimum Basic Data Set for Acute Care Hospitals (CMBD-HA), an audited, mandatory discharge registry covering all acute-care hospitals in the public system. The analytic period spans January 2018-December 2023.
It will include all hospital discharges containing a primary or secondary diagnosis code for septic shock (ICD-10-CM R65.21) or post-procedural septic shock (T81.12XA). This definition prioritises specificity and uniformity across centres. Episodes will be stratified by acquisition setting (community- vs hospital-acquired).
Extracted variables include: demographics (age, sex); comorbidities and morbidity burden (Adjusted Morbidity Groups [GMA] index); infection source; organ failures; advanced life-support interventions (mechanical ventilation, renal replacement therapy, ECMO); ICU admission; length of stay; and mortality.
Primary outcome: in-hospital mortality. Secondary outcomes: 30-day mortality (where available), ICU admission, length of stay, and use of life-support therapies. Preliminary registry summaries show >31,000 episodes across 2018-2023 and, for 2023, an incidence of ~78 per 100,000 with in-hospital mortality ~33% overall (higher in hospital-acquired episodes). These figures motivate the benchmarking component.
Descriptive statistics will summarise case mix and care processes, including incidence rates per 100,000 inhabitants. Multivariable logistic regression will estimate individual mortality risk; model performance will be assessed (e.g., AUROC) and used to generate expected mortality for each hospital. Comparative performance will be reported via O/E mortality ratios with confidence intervals. Length of stay will be modelled after appropriate transformation. Sensitivity analyses will explore the impact of acquisition setting, infection source, organ failures, and comorbidity burden.
Based on audited counts, the registry includes 31,480 septic shock episodes over 2018-2023 (6,182 in 2023), ensuring sufficient precision for risk modelling and hospital-level benchmarking across the regional network.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a diagnosis of septic shock | – | 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.All patients with a diagnosis of septic shock discharged hospitals of the public hospital network of Catalonia, Spain, were included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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.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. | Other | Patients with a diagnosis of septic shock |
Primary outcome
Death due to septic shock
Time frame: From date of hospital admission until the date of hospital discharge, assessed up to 12 months
Inhospital death after an episode of septic shock requiring hospital or ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No. Restrictions apply to the availability of these data, which belong to a national database and is not publicly available.
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josep M Badia, MD, PhD study director
Hospital General de Granollers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Hospital de Granollers at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death due to septic shock (time frame: From date of hospital admission until the date of hospital discharge, assessed up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.