Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06354452
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2024-01-22
Brief Title:
Effect of Statin Therapy on Sepsis-related Mortality in Intensive Care Unit Patients
Sponsor:
Hospital de Granollers
Organization:
Hospital de Granollers
Study Overview
Official Title:
Preadmission Use of Statin Therapy and Sepsis-related Mortality in ICU Patients a Population-based Cohort Study
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HGG_UCI1
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 eg 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 25000 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 shockPatients 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 0001
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
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 25000 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 shockPatients 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 0001
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None