HO-1/CREB3 Modulates Golgi Stress in Patients With Sepsis
- Conditions
- Sepsis
- Interventions
- Other: nothing
- Registration Number
- NCT06045780
- Lead Sponsor
- Tianjin Nankai Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy controls nothing healthy Sepsis nothing disease
- Primary Outcome Measures
Name Time Method cAMP-response element binding protein 3, CREB3 Up to Day 28 CREB3 levels were measured in the PBMCs of sepsis patients and healthy controls
ADP-ribosylation factor 4, ARF4 Up to Day 28 ARF4 levels were measured in the PBMCs of sepsis patients and healthy controls
- Secondary Outcome Measures
Name Time Method Heme oxygnase-1, HO-1 Up to Day 28 HO-1 levels were measured in the PBMCs of sepsis patients and healthy controls
Oxygenation index Up to Day 28 The ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage).
Mechanical ventilation days Up to Day 28 The number of days the patient was alive and mechanical ventilating
Sequential Organ-Failure Assessment (SOFA) score Up to Day 28 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.
ARF family Up to Day 28 ARF1, ARF3, ARF5, ARF6 levels were measured in the PBMCs of sepsis patients and healthy controls
Inflammation biomarkers Inflammation levels Up to Day 28 Procalcitonin (PCT), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1β), and interleukin-6 (IL-6)
ICU stay length Up to Day 90 The number of days the patient was alive and ICU stay
28 days survive Up to Day 28 All Cause Mortality to Day 28
Acute Physiology and Chronic Health Evaluation II (APACHE II) score Up to Day 28 The APACHE II score consists of three parts: acute physiological score, age score, and chronic health score. APACHE II uses a point score (range 0 to 71) based upon initial values of 12 routine physiologic measurements, age, and previous health status to provide a general measure of severity of disease, with an increasing score reflecting worsening organ dysfunction.
Trial Locations
- Locations (1)
Tianjin Nankai Hospital
🇨🇳Tianjin, Tianjin, China