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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sepsis
• Intervention / Treatment: Other: nothing

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Jianbo Yu, MD; Phone Number: +8615344422323; Email: 30717008@nankai.edu.cn

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Tianjin Nankai Hospital
      • Contact: Yuan Zhang, MD; Phone Number: （022）27435027 +8613642066361

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Septic patients and healthy controls

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sepsis; disease	Other: nothing; disease
Healthy controls; healthy	Other: nothing; disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cAMP-response element binding protein 3, CREB3	CREB3 levels were measured in the BALF of sepsis patients and healthy controls	Up to Day 28
ADP-ribosylation factor 4, ARF4	ARF4 levels were measured in the BALF of sepsis patients and healthy controls	Up to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heme oxygnase-1, HO-1	HO-1 levels were measured in the BALF of sepsis patients and healthy controls	Up to Day 28
ARF family	ARF1, ARF3, ARF5, ARF6 levels were measured in the BALF of sepsis patients and healthy controls	Up to Day 28
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
Mechanical ventilation days	The number of days the patient was alive and mechanical ventilating	Up to Day 28
Inflammation biomarkers Inflammation levels	Procalcitonin (PCT), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1β), and interleukin-6 (IL-6)	Up to Day 28
ICU stay length	The number of days the patient was alive and ICU stay	Up to Day 90
28 days survive	All Cause Mortality to Day 28	Up to Day 28
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
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

Collaborators and Investigators

• Sponsor: Tianjin Nankai Hospital
• Investigators: Study Director: Jianbo Yu, MD, Tianjin Nankai Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2023
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): November 15, 2024

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: NKYY_YXKT_IRB_2023_049_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No