SepsisNCT06045780
HO-1/CREB3 Modulates Golgi Stress in Patients With Sepsis
An observational study of Sepsis, run by Tianjin Nankai Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- What is being tested?
- nothing
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2023to 15 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Septic patients and healthy controls
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Nankai Hospital
Tianjin, Tianjin Municipality, 300000
Yuan Zhang, MD, +8613642066361 ext. （022）27435027
About this study
Official title: 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.
Read the 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.
- Conditions
- Sepsis
- Being tested
- nothing
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nothingOther
disease
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | disease Receives: Other: nothing | |
| Healthy controls | healthy Receives: Other: nothing |
What is being measured
The primary outcome is the main question the study is designed to answer.
cAMP-response element binding protein 3, CREB3
CREB3 levels were measured in the PBMCs of sepsis patients and healthy controls
Measured: Up to Day 28
ADP-ribosylation factor 4, ARF4
ARF4 levels were measured in the PBMCs of sepsis patients and healthy controls
Measured: Up to Day 28
Secondary outcomes (9)
Heme oxygnase-1, HO-1
HO-1 levels were measured in the PBMCs of sepsis patients and healthy controls
Measured: Up to Day 28
ARF family
ARF1, ARF3, ARF5, ARF6 levels were measured in the PBMCs of sepsis patients and healthy controls
Measured: 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).
Measured: Up to Day 28
Mechanical ventilation days
The number of days the patient was alive and mechanical ventilating
Measured: 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)
Measured: Up to Day 28
ICU stay length
The number of days the patient was alive and ICU stay
Measured: Up to Day 90
28 days survive
All Cause Mortality to Day 28
Measured: 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.
Measured: 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. 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.
Measured: Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start15 Sep 2023
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Nankai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianbo Yu, Tianjin Nankai Hospital
- Investigators
- Jianbo Yu, MD, Study director, Tianjin Nankai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045780
- Sponsor's protocol ID
- NKYY_YXKT_IRB_2023_049_01
- Status last verified
- Jul 2024
- First submitted
- 13 Sep 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31573637
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Mechanism of Endotoxic Acute Lung Injury-induced Golgi Stress Based on Regulating HO-1/CREB3
- ClinicalTrials.gov ID
- NCT06045780
- Acronym / sponsor ID
- NKYY_YXKT_IRB_2023_049_01
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tianjin Nankai HospitalUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | Other: nothingdisease |
| Healthy controls | – | Other: nothinghealthy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Septic patients and healthy controls
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nothingdisease | Other | Healthy controls, Sepsis |
Primary outcome
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
9 secondary outcomes
Heme oxygnase-1, HO-1
Time frame: Up to Day 28
ARF family
Time frame: Up to Day 28
Oxygenation index
Time frame: Up to Day 28
Mechanical ventilation days
Time frame: Up to Day 28
Inflammation biomarkers Inflammation levels
Time frame: Up to Day 28
ICU stay length
Time frame: Up to Day 90
28 days survive
Time frame: Up to Day 28
Sequential Organ-Failure Assessment (SOFA) score
Time frame: Up to Day 28
Acute Physiology and Chronic Health Evaluation II (APACHE II) score
Time frame: Up to Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 31573637Fowler 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.
- Individual participant dataSharing planned: No
Related trials for Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Integrated Medicine for Sepsis: An RCT With Phenotyping
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianbo Yu, MD study director
Tianjin Nankai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Tianjin Nankai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianbo Yu, MD (+8615344422323, 30717008@nankai.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cAMP-response element binding protein 3, CREB3 (time frame: Up to Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06045780, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.