Sepsis in the nonhospital setting

doi:10.21203/rs.3.rs-2451901/v1

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Sepsis in the nonhospital setting

https://doi.org/10.21203/rs.3.rs-2451901/v1

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Journal Publication

published 30 Jun, 2023

Read the published version in Scientific Reports →

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Introduction

Sepsis is a disease with high mortality and morbidity. Despite advances in diagnosis and therapeutic packages, many gaps remain. This study aimed to evaluate the profile and outcomes of out-of-hospital sepsis.

Methods

This was a retrospective study, multicenter study including five basic health Unit. The study period was from January 2018 to December 2021.Patients diagnosed with sepsis or septic shock according to the Sepsis 3.0 criterion.

Results

A total 2630 patients were included with a diagnosis of sepsis 68.4% (1800) or septic shock 31.6% (830) in the emergency care units. The comorbidities that were independent predictors of septic shock were chronic kidney disease on dialysis (CKD-d), bone marrow transplantation and neoplasia; CKD and neoplasia were also independent predictors of mortality, with ORs of 2.00 (CI 1.10–3.68) p = 0.023 and 1.74 (CI 1.319–2.298) p = < 0.0001, respectively. Mortality according to the focus of primary infection was as follows: pulmonary 40.1%; COVID-19 35.7%; abdominal 8.1% and urinary 6.2%. Mortality due to the COVID-19 outbreak had an OR of 4.94 (CI 3.08–8.13) p ≤ 0.0001.

Conclusions

The following are risk factors associated with mortality in nonhospitalized sepsis: comorbidities (d-CKD and neoplasia) and the primary focus of COVID-19 infection.

Health sciences/Risk factors

Health sciences/Signs and symptoms/Comorbidities

Health sciences/Pathogenesis/Infection

Sepsis

COVID-19

Infections

Pathological conditions

signs and symptoms

Diagnosis

Sepsis affects 750,000 patients each year in the United States and is the leading cause of death in critically ill patients, killing more than 210,000 people every year. 1 Approximately 15% of patients with sepsis experience septic shock, which is responsible for approximately 10% of intensive care unit (ICU) admissions and has a mortality rate of approximately 50%. 1

Some concepts of sepsis definition and management have evolved in recent decades, and the last international consensus occurred in 2016, known as Sepsis-3.0 2 Sepsis is a potentially fatal organ dysfunction caused by a dysregulated immune response to bacterial, viral, fungal and protozoan infection. 2 The diagnosis of viral etiology sepsis, particularly among patients with COVID-19, is poorly promoted (3–5), and this may reduce adherence to the sepsis protocol. A meta-analysis including more than 37,000 patients showed an incidence of sepsis in patients with COVID-19 of 17.7% (95% CI, 12.9–23.6) in the ward and 77.9% in the ICU (95% CI, 75.9–79.8). 6

There are few studies reporting the panorama of sepsis in nonhospital settings such as emergency care units, and the profile, risk factors (comorbidities), and focus of primary infection in individuals with nonhospital sepsis are not clear. The present study aimed to evaluate the profile of sepsis in the community and the clinical outcomes.

Cohort characteristics, comorbidities and outcomes

A total of 2630 patients were included with a diagnosis of sepsis 68.4% (1800) and septic shock 31.6% (830) in the basic health Unit. The characteristics of the cohort are presented in Table 1. The age was 73.55 with PD (17.55); younger individuals 72.39 PD (16.89) had a higher incidence of septic shock versus 74.03 PD years (17.83) for sepsis p 0.001; males represented 1557 (59.2%) of the cohort.

Table 1

Cohort characteristics, comorbidities, and outcomes
	TOTAL	SEPSIS	SEPTIC SHOCK	Q
Age	73.52 DP (17.55)	74.03 DP (17.83)	72.39 DP (16.89)	0.001
Sex	1557 (59.2%)	1058 (58.8%)	498 (60%)	0.605
Comorbidities
Neoplasm	442 (16.8%)	278 (62.9%)	164 (37.1%)	0.004
Marrow_Tx	12 (5%)	4 (33.3%)	8 (66.7%)	0.013
CKD_HD	65 (2.5%)	28 (43.1%)	37 (56.9%)	< 0.0001
CKD_No_HD	153 (5.8%)	97 (63.4%)	56 (36.6%)	0.1
Tx_Kidney	17 (0.6%)	11 (64.7%)	6 (35.3%)	0.46
CHF	274 (10.4%)	197 (71.9%)	77 (28.1%)	0.107
AMI_angina_ICO	127 (4.8%)	87 (68.5%)	40 (31.5%)	0.535
Heart disease	563 (21.4%)	379 (67.3%)	184 (32.7%)	0.28
SAH	1112 (42.3%)	749 (67.4%)	362 (32.6%)	0.184
COPD	257 (9.8%)	182 (70.8%)	75 (29.2%)	0.212
Diabetes Mellitus	713 (27.1%)	478 (67%)	235 (33%)	0.19
CIRRHOSIS	15 (0.6%)	8 (53.3%)	7 (46.7%)	0.162
Liver_tx	9 (0.3%)	7 (77.8%)	2 (22.2%)	0.42
HIV	22 (0.8%)	17 (77.3%)	5 (22.7%)	0.258
Brain stroke	200 (7.6%)	136 (68.3%)	63 (31.7%)	0.981
Alzheimer’s dementia	326 (12.4%)	229 (70.2%)	97 (29.8%)	0.244
Charlson index	1.95 (2.14)	1.84 (2.06)	2.16 (2.29)	< 0.0001
Outcomes
SAPS3	52.10 DP (10.15)	50.29 DP (8.82)	55.86 DP (11.62)	< 0.0001
SOFA	3.36 DP (2.14)	2.93 DP (1.47)	4.29 DP (2.29)	< 0.0001
Time in ICU	5.59 DP (13.07)	4.33 DP (10.35)	8.31 DP (17.27)	< 0.0001
Length of hospital stay	17.48 DP (24.71)	13.37 DP (18.10)	26.40 DP (33.31)	< 0.0001
Need for RRT	263 (10%)	62 (23.6%)	201 (76.4%)	< 0.0001
Mortality	322 (12.2%)	73 (22.7%)	249 (77.3%)	< 0.0001
Data are expressed as n (%), mean ± SD, median and percentile (25–75) according to their distribution. tx (transplant), CKD (chronic kidney disease), HD (hemodialysis), CHF (Congestive heart failure), AMI (acute myocardial infarction), ICO (coronary insufficiency). SAH (systemic arterial hypertension), COPD (chronic obstructive pulmonary disease),, HIV (human immunodeficiency virus), ICU (intensive unit care), SAPS (Simplified Acute Physiology Score), SOFA (Sequential Organ Failure Assessment), RRT (renal replacement therapy), .

The comorbidities were systemic arterial hypertension 1112 (42.3%), diabetes mellitus 713 (27.1%), heart disease 563 (21.4%), neoplasms 442 (16.8%), dementia 326 (12.4%), heart failure 274 (10.4%), chronic obstructive pulmonary disease (9.8%), stroke (7.6%), chronic kidney disease (CKD) not on dialysis (5.8%), acute infarction myocardial infarction (4.8%), CKD on dialysis (5.8%), human immunodeficiency virus (HIV) (0.8%), kidney transplant (tx) (0.6%), cirrhosis (0.6%), bone marrow tx (0.5%) and liver tx (0.3%). The Charlson index was 1.95 SD 2.14, being higher in patients with septic shock 2.16 SD (2.29) than those with sepsis 1.84 (2.06) p < 0.0001.

Ninety-seven (3.69%) patients required hospitalization, 1382 (52.55%) required a place in the semi-intensive care unit, and 1151 (43.76%) required a place in the intensive care unit (ICU). The length of stay in the ICU was 5.59 days (SD 13.07) and the hospital stay was 17.48 days (SD 24.71). The need for renal replacement therapy occurred in 263 (10%) of the cohort, ICU time, hospitalization and need for RRT were significantly higher in patients with septic shock p < 0.0001.

The mortality rate for patients with sepsis was 9.6% and for those with septic shock, 23.3% (p < 0.0001). The comorbidities most associated with septic shock were CKD on dialysis 56.9% –(OR 2.949, CI 1.792–4.853, p ≤ 0.0001), bone marrow transplant 66.7% (OR 4.365, CI 1.31–14.54, p = 0.013), neoplasms 37.1% (OR 1.346, CI 1.09–1.68, p = 0.004) (Table 2, Fig. 1). The comorbidity variables that proved to be independent predictors of mortality were CKD on dialysis (OR 2.00,CI 1.10–3. 68, p = 0.023), neoplasia (OR 1.74, CI 1.319–2.298, p ≤ 0.0001.

Table 2

Odds ratio for septic shock and mortality outcomes
	Septic shock			Mortality
Parameters:	Odds ratio	IC	p value	Odds ratio	IC	p value
Age	1.00	(0.996–1.012)	0.365	1.04	(1.02–1.05)	< 0.001
Charlson	1.06	(0.993–1.138)	0.073	1.19	(1.118–1.271)	< 0.001
SOFA				1.27	(1.195–1.34)	< 0.001
CKD	2.95	(1.729–4.853)	< 0.0001	2.00	(1.10–3.68)	0.023
Neoplasm	1.35	(1.09–1.68)	0.004	1.28	(0.88–3.44)	0.196
Bone marrow transplantation	4.37	(1.31–14.54)	0.013	1.74	(1.319–2.298)	< 0.0001
Abdominal Focus	0.73	(0.371–1.424)	0.359	0.77	(0.420–1.392)	0.385
COVID-19 focus	8.65	(5.310-14.749)	< 0.001	4.94	(3.078–8.129)	< 0.001
Pulmonary Focus	1.11	(0.682–1.880)	0.689	0.85	(0.548–1.364)	0.494
Urinary Focus	0.69	(0.367–1.306)	0.252	0.34	(0.177–0.645)	0.001
CKD (chronic kidney disease), SOFA (Sequential Organ Failure Assessment),

The most prevalent primary foci were pulmonary 1135 (43.2%), urinary 469 (17.8%), COVID-19 434 (16.5%), abdominal 316 (12%) and other 276 (10.5%). Mortality according to the focus of primary infection was as follows: pulmonary 40.1%; COVID-19 35.7%; abdominal 8.1% and urinary 6.2%. In the logistic regression for mortality according to focus: pulmonary OR 0.85 (CI 0.55–1.36, p = 0.49), COVID-19 OR 4.94 (CI 3.08–8.13, p ≤ 0.0001), abdominal OR 0.77 (CI 0.42–1.39, p = 0.10); urinary OR 0.34 (CI 0.18–0.65, p < 0.0001) (Table 2).

There are uncertainties regarding community-onset sepsis, gaps ranging from its incidence, risk factors, the need for intensive support, progression to septic shock and mortality. The present study demonstrated in a cohort of patients with nonhospital origin sepsis that 43.76% required a place in the intensive care unit; mortality was 9.6% in sepsis and 31.6% in septic shock.

Studies show a higher mortality rate of sepsis in the hospital setting, 19.2%, versus community-acquired 8.6% (7). In our cohort, although sepsis had a mortality rate of 9.6%, septic shock had a high mortality rate of 31.6%, close to the values in the hospital environment, 33% (8), which indicates constant attention to the early diagnosis and immediate treatment of this pathology outside the hospital setting.

Slightly younger individuals more often progressed to septic shock, and sepsis was more common in healthy young people than in those with comorbidities (mean age, 58.0 ± 19.8 years vs. 67.0 ± 16.5 years). However, this group required less intensive support as the length of hospital stay was reduced but had higher short-term mortality (9.10).

There has been even greater uncertainty regarding the incidence and risk factors for community-onset sepsis. A meta-analysis reported risk factors for sepsis as older age, diabetes and medical conditions (e.g., immunosuppression, lung disease and peripheral arterial disease) (11). Another study found diabetes (15.75%), neoplasia (14.96%) and HIV infection (12.9%) to be common underlying diseases in sepsis (12).

In our cohort, comorbidities, neoplasia, bone marrow transplantation and dialysis CKD were independent predictors of septic shock, and neoplasia and dialysis CKD were independent predictors of mortality. A common mediator between them and likely associations reflect an underlying abnormal immune status that may predispose individuals to sepsis (13).

Sepsis disproportionately affects immunocompromised populations, including recipients of allogeneic hematopoietic cell transplants (14). In immunosuppressed individuals, sepsis has less common presentations, presents with subtle clinical findings, and progresses more rapidly than in immunocompetent populations (15). In our study, bone marrow transplantation showed an OR of 4.365 (CI 1.31–14.54, p = 0.013) for septic shock.

Individuals with CKD on dialysis require venous or peritoneal access for therapy, which is a gateway to infections, and approximately 29.8% of these patients develop sepsis, which is a major cause of mortality in this population (16). The patients on CKD dialysis in our cohort showed an OR of 2.949 (CI 1.792–4.853, p ≤ 0.0001) for septic shock and 2.00 (CI 1.10–3.68, p = 0.023) for mortality.

Cancer-related sepsis was associated with an adjusted absolute increase in hospital mortality ranging from 2.2–15.2% compared with noncancer-related sepsis (17). More than 1 in 5 hospitalizations for sepsis occurs in patients diagnosed with cancer. In-hospital mortality in cancer-related sepsis is 28%, compared to 20% in noncancer-related sepsis (8). Our neoplasm study had an OR of 1.346 (CI 1.09–1.68, p = 0.004) for septic shock and 1.74 (CI 1.319–2.298, p ≤ 0.0001 for mortality.

The etiology of sepsis is essential for health promotion strategies and alerts the community and health professionals. The most prevalent foci found in our cohort were urinary (33%), gastrointestinal (18%) or respiratory (18.26%) foci, and mortality was higher in pulmonary disease and COVID-19 foci (40.1% and 35.7%, respectively) and lower in abdominal (8.1%) and urinary (6.2%) foci, respectively. Sources in the literature corroborate these findings regarding the prevalence and higher mortality in pulmonary foci and lower mortality in the genitourinary foci (18 and 19).

Our study evaluated COVID-19 as a focus of infection and not only as a pathogen, as little was known about the pathology at the beginning of the pandemic. Severe COVID-19 increases the serum levels of cytokines and chemocytokines that are also common in sepsis (6–9). Because the treatment of viral sepsis is not clear, this pathology has been underreported for years (3–5). Our cohort showed that sepsis with an outbreak due to COVID-19 killed more than other foci (OR 4.94, CI 3.08–8.13, p ≤ 0.0001) and was the main independent predictor of progression to septic shock (OR 8.65, 5.31–14.75, p < 0.0001).

This study has some limitations. First, the location of this study was in private basic health Unit, which may not reflect the reality of health services in general. Second, the study did not describe the treatment of sepsis and other conditions that may influence the final outcome. Third, because COVID-19 is a viral condition, it may have been partially neglected, and the outcome was not associated with the causality of the etiology of the pathogen but with the difficulty in managing the viral sepsis. Finally, because it includes periods of pandemic, the mortality results may be linked to the potential difficulty of ICU vacancy and intensive care resources.

Sepsis requires attention, even in nonhospital settings, and the need for advanced resources, such as open beds in intensive care, is frequent, resulting in a high mortality rate from septic shock.

The study revealed that CKD-d comorbidity and neoplasias were associated with septic shock and mortality and that COVID-19 infection has a higher mortality rate than other infections.

Despite the efforts and progress regarding COVID-19, there are still some unclear points such as: viral infection in sepsis and the association of viral sepsis by COVID-19 with higher mortality.

Patients

This was a multicenter, retrospective, cross-sectional and quantitative study including five emergency care units. The study period was from January 2018 to December 2021, and a total of 2630 patients were eligible for the study, with follow-up until the clinical outcome (discharge/death). The Ethics Committee of the Hospital Israelite Albert Einstein approved the study under protocol number CAAE: 55693222.0.0000.0071. The need for consent was waived and approved by Ethics Committee of the Hospital Israelite Albert Einstein, the reason because the research did not involve more than minimal risk to the data confidentiality participants, could not be conducted virtually without waivers, and waivers would not negatively affect the rights and well-being of the participants. The electronic data capture was system “Research Electronic Data Capture” (REDCap) hosted on the servers of Hospital Israelite Albert Einstein. All data was made available to researchers in a deidentified to protect the identity participant and ensure data integrity. The study site was five emergency care units managed by a private institution located in the state of São Paulo, Brazil. The inclusion criteria were as follows: age older than 18 years and diagnosis of sepsis or septic shock. The exclusion criteria were as follows: patients with a Sequential Organ Failure Assessment (SOFA) score lower than 2 points, patients in palliative care and patients with previous dysfunctions related to other diagnoses.

All clinical and research activities being reported are consistent with the Principles of the Declaration of Istanbul, with the Declaration of Helsinki and the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines for cohort studies.

Clinical criteria of sepsis and septic shock

In this study, the Third International Consensus on Definitions for Sepsis and Septic Shock (Sepsis-3), published in 2016, was used to identify adults with suspected infection (2). The laboratory variables, partial pressure of oxygen (Pa O2), platelet count, creatinine and bilirubin levels, are necessary for the screening and performance of the score. In addition, an evaluation of the patient’s level of consciousness is required (Glasgow Coma scale) and the calculation of Mean Arterial Pressure (MAP) (2). In this evaluation, variables are scored 0 to 4; thus, the patient who has 2 or more SOFA points in the presence of an infection is diagnosed with sepsis.

Sepsis is a potentially fatal organ dysfunction caused by a dysregulated immune response to infection. Septic shock occurs in sepsis with nonvolume-refractory hypotension, in which the use of vasopressors is required to maintain a mean arterial pressure (MAP) of 65 mmHg and a serum lactate level equal to or above 18 mg/dL (2 mmol/L) (2).

Statistical Analysis

The extraction of variables was performed using the database of the REDCap® utility. Outcomes such as the incidence of comorbidities in sepsis and septic shock, the focus of infection and mortality were evaluated.

Categorical variables are expressed as numbers (%), and continuous variables are expressed as the means and standard deviations, whereas nonparametric variables are expressed as medians and 25th-75th percentiles. The Gaussian distribution was determined using the Shapiro‒Wilk test. For the correlation (analysis) of the continuous variable with a normal distribution, the t test or Pearson's test was used, and for continuous variables with a nonnormal distribution, the Mann‒Whitney test (Wilcoxon rank) or the Spearman test was used. Categorical data were compared using the chi-square test or Fisher's exact test. Values of p < 0.05 were considered to be statistically significant. In the logistic regression, we used a model to evaluate the comorbidities and the outcome of septic shock, including the following variables: age, Charlson, CKD-d, neoplasia and bone marrow tx; SOFA was included in the evaluation of comorbidities and mortality. The model to analyze the focus of infection and mortality included the variables age, SOFA, Charlson, abdominal focus, focus, pulmonary, urinary focus and COVID-19 focus. The analyses were performed using the Statistical Package for Social Sciences software (SPSS version 20, Chicago, Illinois).

Author contributions

Authors CL and GCA provided the conceptualization of ideas and the evolution of overarching research goals and aims. Authors CL and GCA were responsible for data curation, management activities, maintaining research data, formal analysis, application of statistics, design of methodology, administrative management and coordinating the planning and execution of the research activity. All authors CL, GCA and AP, conducted a research and investigation process; collection of data/evidence and resources; prepared, created and wrote the original draft and gave final approval of the version to be published. Author CL supervised and had leadership responsibility for the planning and execution of the research activity, including mentorship external to the core team.

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Data availability statement

The anonymized dataset is held by the corresponding author and data may be made available in part for secondary analysis by third parties. Access will be granted upon reasonable request.

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No competing interests reported.

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You are reading this latest preprint version

Sepsis in the nonhospital setting

Status:

Journal Publication

Version 1

Abstract

Introduction

Methods

Results

Conclusions

Figures

Introduction

Results

Cohort characteristics, comorbidities and outcomes

Discussion

Conclusion

Materials And Methods

Patients

Clinical criteria of sepsis and septic shock

Statistical Analysis

Declarations

Author contributions

Conflict of interest statement

Data availability statement

References

Additional Declarations

Status:

Journal Publication

Version 1