Clinical trial NCT06045780: HO-1/CREB3 Modulates Golgi Stress in Patients With Sepsis
Official title: Study on the Mechanism of Endotoxic Acute Lung Injury-induced Golgi Stress Based on Regulating HO-1/CREB3
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Lead sponsor: Tianjin Nankai Hospital
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Septic patients and healthy controls

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.

Eligibility criteria: 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.

Primary outcomes:
measure: cAMP-response element binding protein 3, CREB3
timeFrame: Up to Day 28
measure: ADP-ribosylation factor 4, ARF4
timeFrame: Up to Day 28
Secondary outcomes:
measure: Heme oxygnase-1, HO-1
timeFrame: Up to Day 28
measure: ARF family
timeFrame: Up to Day 28
measure: Oxygenation index
timeFrame: Up to Day 28
measure: Mechanical ventilation days
timeFrame: Up to Day 28
measure: Inflammation biomarkers Inflammation levels
timeFrame: Up to Day 28
measure: ICU stay length
timeFrame: Up to Day 90
measure: 28 days survive
timeFrame: Up to Day 28
measure: Sequential Organ-Failure Assessment (SOFA) score
timeFrame: Up to Day 28
measure: Acute Physiology and Chronic Health Evaluation II (APACHE II) score
timeFrame: Up to Day 28
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Nankai Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Nankai Hospital
name: Jianbo Yu, MD
role: STUDY_DIRECTOR
References:
citation: Fowler AA 3rd, Truwit JD, Hite RD, Morris PE, DeWilde C, Priday A, Fisher B, Thacker LR 2nd, Natarajan R, Brophy DF, Sculthorpe R, Nanchal R, Syed A, Sturgill J, Martin GS, Sevransky J, Kashiouris M, Hamman S, Egan KF, Hastings A, Spencer W, Tench S, Mehkri O, Bindas J, Duggal A, Graf J, Zellner S, Yanny L, McPolin C, Hollrith T, Kramer D, Ojielo C, Damm T, Cassity E, Wieliczko A, Halquist M. Effect of Vitamin C Infusion on Organ Failure and Biomarkers of Inflammation and Vascular Injury in Patients With Sepsis and Severe Acute Respiratory Failure: The CITRIS-ALI Randomized Clinical Trial. JAMA. 2019 Oct 1;322(13):1261-1270. doi: 10.1001/jama.2019.11825.