Intra-abdominal infection
Conditions
Interventions
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients aged >=18 years and <= 75 years; 2.Meeting the criteria for Systemic Inflammatory Response Syndrome* (onset <= 72 hours) accompanied by signs of peritonitis; 3.Scheduled to undergo emergency surgery; 4.American Society of Anesthesiologists (ASA) Physical Status Classification I–V; 5.Including but not limited to: appendicitis, cholecystitis, intestinal obstruction, gastrointestinal perforation, etc; 6.Understand and comply with protocol requirements, and voluntarily sign the informed consent form to participate in this study;
Exclusion criteria
Exclusion criteria: 1.Patients participating in other clinical studies; 2.Patients with confirmed ARDS at the time of enrollment (according to the 2023 Global New Definition of ARDS); 3.Female patients who are pregnant, breastfeeding, or may be pregnant; 4.Patients with concomitant chest trauma; 5.Patients with concomitant pneumonia or chronic lung disease (e.g., COPD, asthma, etc.); 6.Patients who have undergone surgical treatment within 30 days prior to screening; 7.Patients with an expected survival of 5 × ULN, or total bilirubin (TBil) = 3 × ULN, or presence of acute liver failure; 10.Patients receiving methylprednisolone at a dose of >= 1 mg/kg/day (or equivalent dose of glucocorticoid) within 7 days prior to enrollment; 11.Patients with baseline platelet count < 50 × 10^9/L or active major bleeding; 12.Patients whom the investigator considers to be at unacceptably high safety risk or unlikely to complete key evaluations; 13.Patients deemed unsuitable for this study by the investigator (e.g., patients with psychiatric disorders);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who completed =144 hours of continuous pump infusion;treatment-related discontinuation rate;enrollment rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative ICU admission rate; Length of hospital stay (hours);Cumulative defined daily dose (DDD) of antibiotics from the first dose (T0) to Day 28 (according to standard).;Incidence of ARDS within 6 days (144 hours) from the first dose (T0);ICU-free days from first dose (T0) to Day 28.;Oxygenation index (PaO2/FiO2) or SpO2/FiO2 on Day -1, Day 0 (start of surgery), Day 1, Day 3, and Day 5.;Inflammatory marker levels in peripheral blood; coagulation parameters; and improvement from baseline in APACHE II and SOFA 2.0 scores on Day -1, 1, 3, and 5.;Days of antibiotic use from the first dose (T0) to Day 28.;Days 0-28: 28-day clinical improvement.;All-cause mortality from the first dose (T0) to Day 28 and Day 90.;Duration of SIRS from first dose (T0) (hours);Respiratory support-free (nasal cannula, HFNC, MV, ECMO), mechanical ventilation-free, and organ support-free (dialysis, assisted ventilation, vasopressors) hours from T0 to Day 28.; | — |
Countries
China
Contacts
Public ContactPeng Guo
Peking University People's Hospital
Outcome results
None listed