SepsisHGG_UCI1NCT06354452
Effect of Statin Therapy on Sepsis-related Mortality in Intensive Care Unit Patients
An observational study of Sepsis and Septic Shock, run by Hospital de Granollers at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- 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.
- How many people
- 59,578 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2018to 31 Jan 2020
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 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).
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preadmission Use of Statin Therapy and Sepsis-related Mortality in ICU Patients: a Population-based Cohort Study.
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.
Read the detailed description
The hypothesis of the study is that poor baseline health status, defined by frailty, comorbidities and chronic drug use, determines sepsis survival and long-term functional status of surviving patients. In addition, the study aims to analize the relationship between different groups of drugs, especially sarcopenal drugs, and sepsis survival in patients admitted to hospitals and Intensive Care Units in a region of 8 million inhabitants. Preliminary data suggest that patients with prior corticosteroid use have poorer survival to sepsis, while chronic statin use may be a protective factor.
This will be a retrospective population-based observational analysis of a large cohort of patients with sepsis using a population-based database over a 2-year period.
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. The registry is intended for the evaluation and optimisation of the use of resources, provides support and improves healthcare planning and facilitates the management of purchases and payments. A cohort of approximately 25,000 patients per year is available from the aforementioned databases (2). Data from 2018 and 2019 (pre-pandemic) will be initially included.
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.Patients requiring Intensive Care Unit (ICU) admission were identified from the coded procedures of mechanical ventilation, continuous renal replacement techniques (CRRT), tracheostomy, or extracorporeal membrane oxygenation (ECMO).
To analyse outpatient prescriptions, a patient will be considered to have prior treatment with a given medication if, during the 8 months prior to admission for sepsis, a minimum of 6 containers of that drug had been dispensed. The Anatomical, Therapeutic, Chemical (ATC) drug classification of the World Health Organization (WHO) will be used.
An analysis of demographics, risk factors, baseline status, comorbidities, and previous dependence on health services of all patients admitted to hospitals in the region will be carried out. Overall patients admitted to hospitals and those admitted to ICU will be analysed separately. Survival data will be compared with previous drug use, trying to find out the relationship between dependence to some groups of these drugs and survival to sepsis. In addition, drug dependence and health services dependence of sepsis survivors will be studied in comparison with their pre-sepsis situation.
A descriptive analysis of the baseline characteristics of the sample will be performed using absolute values and percentages or mean and standard deviation, as appropriate. To establish the relationship between the dependent and independent variables, a bivariate analysis will be performed using the chi-square or t-Student test, as appropriate. A logistic regression model will be applied to determine the risk factors for mortality, analysing the scores for comorbidities, frailty (defined as emergency admissions, being a resident or institutionalised, being previously defined as a complex chronic patient or advanced chronic disease) and chronic consumption of certain families of drugs, for all those variables that had obtained statistical significance in the bivariate analysis. Statistical significance will be established with a p-value of less than 0.001.
The creation of the scale predictive of mortality will be based on the combination of the risk factors detected in the previous logistic regression analyses. The reliability and validity of the scale for subgroups of the sample will be analysed to check that the psychometric characteristics of the instrument were valid for the different types of population. To study sepsis mortality, Cox regression models or competing risk models will be performed, comparing baseline states and different pharmacological treatments.
The impact on health care consumption of patients who do not survive sepsis will be based on data from the Catalan Health System (CatSalut) Minimum Basic Data Set (CMBD) registers, and it will not be an economic study using cost-effectiveness or health-assessment methodologies.
- Conditions
- Sepsis, Septic Shock
- Being tested
- 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.
- Keywords
- Sepsis, Mortality, Statins, Corticoid
- Medical subject headings
- Sepsis, Shock, Septic
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death due to sepsis
Inhospital death after an episode of sepsis 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 posted9 Apr 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- 59,578 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya
- Responsible party
- Principal investigator, Josep Maria Badia, Hospital de Granollers
- Investigators
- Josep M Badia, MD, PhD, Study director, Hospital General de Granollers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354452
- Sponsor's protocol ID
- HGG2024_01
- Acronym
- HGG_UCI1
- Status last verified
- Apr 2024
- First submitted
- 22 Jan 2024
- Last updated
- 9 Apr 2024
- 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.
Publications
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.
PubMed 41625328Iglesias 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;166(1):107265. doi: 10.1016/j.medcli.2025.107265. Epub 2026 Jan 7. English, Spanish.
PubMed 41505944
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preadmission Use of Statin Therapy and Sepsis-related Mortality in ICU Patients: a Population-based Cohort Study.
- ClinicalTrials.gov ID
- NCT06354452
- Acronym / sponsor ID
- HGG_UCI1 / HGG2024_01
- Conditions
- Sepsis, Septic Shock
- Keywords
- Sepsis, Mortality, Statins, Corticoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59,578 participants (actual)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 9 Apr 2024 (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.
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.
Detailed description
The hypothesis of the study is that poor baseline health status, defined by frailty, comorbidities and chronic drug use, determines sepsis survival and long-term functional status of surviving patients. In addition, the study aims to analize the relationship between different groups of drugs, especially sarcopenal drugs, and sepsis survival in patients admitted to hospitals and Intensive Care Units in a region of 8 million inhabitants. Preliminary data suggest that patients with prior corticosteroid use have poorer survival to sepsis, while chronic statin use may be a protective factor.
This will be a retrospective population-based observational analysis of a large cohort of patients with sepsis using a population-based database over a 2-year period.
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. The registry is intended for the evaluation and optimisation of the use of resources, provides support and improves healthcare planning and facilitates the management of purchases and payments. A cohort of approximately 25,000 patients per year is available from the aforementioned databases (2). Data from 2018 and 2019 (pre-pandemic) will be initially included.
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.Patients requiring Intensive Care Unit (ICU) admission were identified from the coded procedures of mechanical ventilation, continuous renal replacement techniques (CRRT), tracheostomy, or extracorporeal membrane oxygenation (ECMO).
To analyse outpatient prescriptions, a patient will be considered to have prior treatment with a given medication if, during the 8 months prior to admission for sepsis, a minimum of 6 containers of that drug had been dispensed. The Anatomical, Therapeutic, Chemical (ATC) drug classification of the World Health Organization (WHO) will be used.
An analysis of demographics, risk factors, baseline status, comorbidities, and previous dependence on health services of all patients admitted to hospitals in the region will be carried out. Overall patients admitted to hospitals and those admitted to ICU will be analysed separately. Survival data will be compared with previous drug use, trying to find out the relationship between dependence to some groups of these drugs and survival to sepsis. In addition, drug dependence and health services dependence of sepsis survivors will be studied in comparison with their pre-sepsis situation.
A descriptive analysis of the baseline characteristics of the sample will be performed using absolute values and percentages or mean and standard deviation, as appropriate. To establish the relationship between the dependent and independent variables, a bivariate analysis will be performed using the chi-square or t-Student test, as appropriate. A logistic regression model will be applied to determine the risk factors for mortality, analysing the scores for comorbidities, frailty (defined as emergency admissions, being a resident or institutionalised, being previously defined as a complex chronic patient or advanced chronic disease) and chronic consumption of certain families of drugs, for all those variables that had obtained statistical significance in the bivariate analysis. Statistical significance will be established with a p-value of less than 0.001.
The creation of the scale predictive of mortality will be based on the combination of the risk factors detected in the previous logistic regression analyses. The reliability and validity of the scale for subgroups of the sample will be analysed to check that the psychometric characteristics of the instrument were valid for the different types of population. To study sepsis mortality, Cox regression models or competing risk models will be performed, comparing baseline states and different pharmacological treatments.
The impact on health care consumption of patients who do not survive sepsis will be based on data from the Catalan Health System (CatSalut) Minimum Basic Data Set (CMBD) registers, and it will not be an economic study using cost-effectiveness or health-assessment methodologies.
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 sepsis | – | 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.All patients with a diagnosis of sepsis admitted to the 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 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).
Key inclusion criteria (1 listed)
- 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.
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 sepsis survival and previous intake of certain drug families 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 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. | Other | Patients with a diagnosis of sepsis |
Primary outcome
Death due to sepsis
Time frame: From date of hospital admission until the date of hospital discharge, assessed up to 12 months
Inhospital death after an episode of sepsis requiring hospital or ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Derived from this study: PubMed 41625328Iglesias 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.
- Derived from this study: PubMed 41505944Iglesias 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;166(1):107265. doi: 10.1016/j.medcli.2025.107265. Epub 2026 Jan 7. English, Spanish.
- 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 Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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 Sepsis and 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: finished, as of the sponsor's last update on 9 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 sepsis (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?
On the ClinicalTrials.gov record for NCT06354452, which also lists 2 linked publications.
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 9 Apr 2024.