HO-1/CREB3 Modulates Golgi Stress in Patients With Sepsis

Study Overview
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Brief Summary
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This study was an ambispective observational cohort study that included sepsis patients hospitalized in the Intensive care unit (ICU) of the Nankai Hospital. All patients met the consensus criteria of sepsis-3. The purpose of this study is to investigate the valuable biomarkers for the severity of sepsis and predictors of 30-day mortality for patients with sepsis.

Detailed Description
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All patients met the consensus criteria of sepsis-3. The purpose of this study is to investigate the valuable biomarkers for the severity of sepsis and predictors of 30-day mortality for patients with sepsis.

Official Title
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Study on the Mechanism of Endotoxic Acute Lung Injury-induced Golgi Stress Based on Regulating HO-1/CREB3

Conditions
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Sepsis

Intervention / Treatment
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* Other: nothing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females over the age of 18; Sepsis was diagnosed within 48h which meets SPESIS 3 criteria; Capable of understanding the purpose and risk of the study; Patients or proxy must give written informed consent before any assessment is performed. Exclusion Criteria: Pregnancy, lactation or perinatal period; Breast carcinoma; HIV seropositive or Syphilis seropositive; Any clinical-relevant condition that might affect study participation and/or study results; Participation in any other intervention trial; Unwillingness or inability to following the study protocol in the investigators opinion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sepsis<br>disease | Other: nothing<br>* disease<br>|
| Healthy controls<br>healthy | Other: nothing<br>* disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cAMP-response element binding protein 3, CREB3 | CREB3 levels were measured in the BALF of sepsis patients and healthy controls | Up to Day 28 | 
| ADP-ribosylation factor 4, ARF4 | ARF4 levels were measured in the BALF of sepsis patients and healthy controls | Up to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heme oxygnase-1, HO-1 | HO-1 levels were measured in the BALF of sepsis patients and healthy controls | Up to Day 28 | 
| ARF family | ARF1, ARF3, ARF5, ARF6 levels were measured in the BALF of sepsis patients and healthy controls | Up to Day 28 | 
| Oxygenation index | The ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage). | Up to Day 28 | 
| Mechanical ventilation days | The number of days the patient was alive and mechanical ventilating | Up to Day 28 | 
| Inflammation biomarkers Inflammation levels | Procalcitonin (PCT), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1β), and interleukin-6 (IL-6) | Up to Day 28 | 
| ICU stay length | The number of days the patient was alive and ICU stay | Up to Day 90 | 
| 28 days survive | All Cause Mortality to Day 28 | Up to Day 28 | 
| Sequential Organ-Failure Assessment (SOFA) score | The SOFA score is used to assess the severity and prognosis of sepsis.SOFA was based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction. | Up to Day 28 | 
| Acute Physiology and Chronic Health Evaluation II (APACHE II) score | The APACHE II score consists of three parts: acute physiological score, age score, and chronic health score. | Up to Day 28 |