Clinical trial NCT06756750: Clinical Characteristics and Risk Factors for In-Hospital Mortality in Surgical Patients With Abdominal Sepsis
Official title: Intraoperative Low-dose Glucocorticoids in Surgical Patients With Abdominal Sepsis: A Multicenter Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Glucocorticoid
Keywords: abdominal sepsis
surgical patients
risk factors
general anesthesia
retrospective
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 476
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Meeting the Sepsis 3.0 criteria ;
* Patient's age ≥ 18 years;
* Emergency or elective abdominal surgery.

Exclusion Criteria:

* History of severe cardiopulmonary, hepatic, renal, or other organ damage;
* Preoperative presence of infection other than abdominal;
* Unplanned secondary surgery；
* Receiving preoperative glucocorticoid therapy.

Primary outcomes:
measure: In-hospital mortality
timeFrame: January 2008 - December 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital /Depatment of Anesthesiology, The Air Force Medical Center
state: Beijing
Study officials:
affiliation: Depatment of Anesthesiology, The First Medical Center Affiliation: Chinese PLA General Hospital
name: Weidong Mi
role: STUDY_CHAIR
References: