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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06045780
Enrollment
150
Registered
2023-09-21
Start date
2023-09-15
Completion date
2024-11-15
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

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.

Interventions

OTHERnothing

disease

Sponsors

Tianjin Nankai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

1. Males or females over the age of 18; 2. Sepsis was diagnosed within 48h which meets SPESIS 3 criteria; 3. Capable of understanding the purpose and risk of the study; 4. Patients or proxy must give written informed consent before any assessment is performed.

Exclusion criteria

1. Pregnancy, lactation or perinatal period; 2. Breast carcinoma; 3. HIV seropositive or Syphilis seropositive; 4. Any clinical-relevant condition that might affect study participation and/or study results; 5. Participation in any other intervention trial; 6. Unwillingness or inability to following the study protocol in the investigators opinion.

Design outcomes

Primary

MeasureTime frameDescription
ADP-ribosylation factor 4, ARF4Up to Day 28ARF4 levels were measured in the PBMCs of sepsis patients and healthy controls
cAMP-response element binding protein 3, CREB3Up to Day 28CREB3 levels were measured in the PBMCs of sepsis patients and healthy controls

Secondary

MeasureTime frameDescription
Oxygenation indexUp to Day 28The ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage).
Mechanical ventilation daysUp to Day 28The number of days the patient was alive and mechanical ventilating
Inflammation biomarkers Inflammation levelsUp to Day 28Procalcitonin (PCT), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1β), and interleukin-6 (IL-6)
Heme oxygnase-1, HO-1Up to Day 28HO-1 levels were measured in the PBMCs of sepsis patients and healthy controls
28 days surviveUp to Day 28All Cause Mortality to Day 28
Sequential Organ-Failure Assessment (SOFA) scoreUp to Day 28The 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) scoreUp to Day 28The 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.
ICU stay lengthUp to Day 90The number of days the patient was alive and ICU stay
ARF familyUp to Day 28ARF1, ARF3, ARF5, ARF6 levels were measured in the PBMCs of sepsis patients and healthy controls

Countries

China

Contacts

Primary ContactJianbo Yu, MD
30717008@nankai.edu.cn+8615344422323

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026