Tianjin Nankai Hospital
Tianjin, Tianjin Municipality, 300000, China
Location status: Recruiting
Recruiting
NCT Number: NCT06045780
HO-1/CREB3 Modulates Golgi Stress in Patients With Sepsis
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–100 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
nothing
Otherdisease
Primary outcomes
-
cAMP-response element binding protein 3, CREB3
Time frame: Up to Day 28
CREB3 levels were measured in the PBMCs of sepsis patients and healthy controls
-
ADP-ribosylation factor 4, ARF4
Time frame: Up to Day 28
ARF4 levels were measured in the PBMCs of sepsis patients and healthy controls
Secondary outcomes
-
Heme oxygnase-1, HO-1
Time frame: Up to Day 28
HO-1 levels were measured in the PBMCs of sepsis patients and healthy controls
-
ARF family
Time frame: Up to Day 28
ARF1, ARF3, ARF5, ARF6 levels were measured in the PBMCs of sepsis patients and healthy controls
-
Oxygenation index
Time frame: 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
Time frame: Up to Day 28
The number of days the patient was alive and mechanical ventilating
-
Inflammation biomarkers Inflammation levels
Time frame: 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
Time frame: Up to Day 90
The number of days the patient was alive and ICU stay
-
28 days survive
Time frame: Up to Day 28
All Cause Mortality to Day 28
-
Sequential Organ-Failure Assessment (SOFA) score
Time frame: 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.
-
Acute Physiology and Chronic Health Evaluation II (APACHE II) score
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Tianjin Nankai Hospital
Other
Registry information
Official study title
Study on the Mechanism of Endotoxic Acute Lung Injury-induced Golgi Stress Based on Regulating HO-1/CREB3
Important dates
- Study start
- 2023
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Sep 21, 2023
- Registry last updated
- Jul 30, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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