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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06045780
• Other study ID #: NKYY_YXKT_IRB_2023_049_01
• Status: Not yet recruiting
• Start date: September 15, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: September 2023
• Source: Tianjin Nankai Hospital
• Contact: Jianbo Yu, MD
• Phone: +8615344422323
• Email: 30717008[@]nankai.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: November 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis

Intervention

Other:
• nothing
disease

Locations

Country	Name	City	State
China	Tianjin Nankai Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Nankai Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. Erratum In: JAMA. 2020 Jan 28;323(4):379. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cAMP-response element binding protein 3, CREB3	CREB3 levels were measured in the BALF of sepsis patients and healthy controls	Up to Day 28
Primary	ADP-ribosylation factor 4, ARF4	ARF4 levels were measured in the BALF of sepsis patients and healthy controls	Up to Day 28
Secondary	Heme oxygnase-1, HO-1	HO-1 levels were measured in the BALF of sepsis patients and healthy controls	Up to Day 28
Secondary	ARF family	ARF1, ARF3, ARF5, ARF6 levels were measured in the BALF of sepsis patients and healthy controls	Up to Day 28
Secondary	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
Secondary	Mechanical ventilation days	The number of days the patient was alive and mechanical ventilating	Up to Day 28
Secondary	Inflammation biomarkers Inflammation levels	Procalcitonin (PCT), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1ß), and interleukin-6 (IL-6)	Up to Day 28
Secondary	ICU stay length	The number of days the patient was alive and ICU stay	Up to Day 90
Secondary	28 days survive	All Cause Mortality to Day 28	Up to Day 28
Secondary	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
Secondary	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