SepsisNCT06756750
Clinical Characteristics and Risk Factors for In-Hospital Mortality in Surgical Patients With Abdominal Sepsis
An observational study of Sepsis and Glucocorticoid, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
A retrospective study of sepsis patients with abdominal infections who underwent abdominal surgery was conducted in an attempt to reveal the epidemiological characteristics of sepsis after abdominal surgery, risk factors, and to analyze the prognosis of the patients, to reveal indicators of predictive value for the… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sepsis, Glucocorticoid
- How many people
- 476 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 1 May 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
- No healthy volunteers
- Adult, Older adult
Study population: Abdominal septic patients underwent surgical procedures in two large-scale medical centers (the First Medical Center of the Chinese People's Liberation Army [PLA] General Hospital and the Air Force Medical Center) between Jan, 2008 and Dec, 2022 in Beijing, China.
Who may be able to join
- Meeting the Sepsis 3.0 criteria ;
- Patient's age ≥ 18 years;
- Emergency or elective abdominal surgery.
Who cannot join
- History of severe cardiopulmonary, hepatic, renal, or other organ damage;
- Preoperative presence of infection other than abdominal;
- Unplanned secondary surgery；
- Receiving preoperative glucocorticoid therapy.
Trial locations and contacts
1 site in 1 country.
China1 site
Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital /Depatment of Anesthesiology, The Air Force Medical Center
Beijing, Beijing Municipality, 100853/100142
About this study
Official title: Intraoperative Low-dose Glucocorticoids in Surgical Patients With Abdominal Sepsis: A Multicenter Retrospective Cohort Study
A retrospective study of sepsis patients with abdominal infections who underwent abdominal surgery was conducted in an attempt to reveal the epidemiological characteristics of sepsis after abdominal surgery, risk factors, and to analyze the prognosis of the patients, to reveal indicators of predictive value for the prognosis of patients with sepsis, with a view to providing certain evidence for optimizing the perianesthesia management of patients with sepsis.
Read the detailed description
Background and Aims: Abdominal sepsis refers to a severe and potentially life-threatening condition characterized by the presence of infection, inflammation, and tissue damage within the abdominal cavity. Glucocorticoids (GCs) play an important role in regulation of the host immune and inflammation responses involved in sepsis and surgery. This study aimed to investigate the potential impact of intraoperative GCs administration on the clinical outcome of surgical patients with abdominal sepsis.
Methods: This retrospective cohort study included a 1:1 propensity score-matched cohort of surgical patients afflicted with abdominal sepsis at 2 medical centers from January, 2008, through December, 2022. Patients were classified into low-GCs, high-GCs, and non-GCs groups according to the dosage of steroids used intraoperatively, and in-hospital mortality was designated as the primary outcome.
- Conditions
- Sepsis, Glucocorticoid
- Keywords
- abdominal sepsis, surgical patients, risk factors, general anesthesia, retrospective
- Medical subject headings
- Sepsis, Intraabdominal Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Measured: January 2008 - December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Nov 2023
- Primary completion1 Dec 2023
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 476 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingsheng Lou, Chinese PLA General Hospital
- Investigators
- Weidong Mi, Study chair, Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756750
- Sponsor's protocol ID
- PLAGH-AOC-L06
- Status last verified
- Mar 2025
- First submitted
- 27 Dec 2024
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Low-dose Glucocorticoids in Surgical Patients With Abdominal Sepsis: A Multicenter Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06756750
- Acronym / sponsor ID
- PLAGH-AOC-L06
- Conditions
- Sepsis, Glucocorticoid
- Keywords
- abdominal sepsis, surgical patients, risk factors, general anesthesia, retrospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 476 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 3 Jan 2025 (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.
A retrospective study of sepsis patients with abdominal infections who underwent abdominal surgery was conducted in an attempt to reveal the epidemiological characteristics of sepsis after abdominal surgery, risk factors, and to analyze the prognosis of the patients, to reveal indicators of predictive value for the prognosis of patients with sepsis, with a view to providing certain evidence for optimizing the perianesthesia management of patients with sepsis.
Detailed description
Background and Aims: Abdominal sepsis refers to a severe and potentially life-threatening condition characterized by the presence of infection, inflammation, and tissue damage within the abdominal cavity. Glucocorticoids (GCs) play an important role in regulation of the host immune and inflammation responses involved in sepsis and surgery. This study aimed to investigate the potential impact of intraoperative GCs administration on the clinical outcome of surgical patients with abdominal sepsis.
Methods: This retrospective cohort study included a 1:1 propensity score-matched cohort of surgical patients afflicted with abdominal sepsis at 2 medical centers from January, 2008, through December, 2022. Patients were classified into low-GCs, high-GCs, and non-GCs groups according to the dosage of steroids used intraoperatively, and in-hospital mortality was designated as the primary outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Abdominal septic patients underwent surgical procedures in two large-scale medical centers (the First Medical Center of the Chinese People's Liberation Army [PLA] General Hospital and the Air Force Medical Center) between Jan, 2008 and Dec, 2022 in Beijing, China.
Key inclusion criteria (3 listed)
- Meeting the Sepsis 3.0 criteria ;
- Patient's age ≥ 18 years;
- Emergency or elective abdominal surgery.
Key exclusion criteria (4 listed)
- History of severe cardiopulmonary, hepatic, renal, or other organ damage;
- Preoperative presence of infection other than abdominal;
- Unplanned secondary surgery；
- Receiving preoperative glucocorticoid therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital mortality
Time frame: January 2008 - December 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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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.
Weidong Mi study chair
Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General 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 and Glucocorticoid, run by Chinese PLA General 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 28 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: January 2008 - December 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2025.