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 and =75 years old; (2) Systemic inflammatory response syndrome * (onset =72 hours) with signs of peritonitis * Systemic inflammatory response syndrome (4 meets 2 or more) : a. Body temperature > 38 ° C or 90 beats per minute c. Respiratory rate > 20 breaths/minute or partial pressure of carbon dioxide (PaCO2) 12×10^9/L or 10% (3) Planned emergency surgery; (4) American Society of Anesthesiologists (ASA) grade ?-?; (5) Including but not limited to: appendicitis, cholecystitis, intestinal obstruction, gastrointestinal perforation, etc. (6) Understand and comply with the requirements of the protocol, sign the informed consent voluntarily to participate in the study;
Exclusion criteria
Exclusion criteria: (1) patients participating in other clinical research; (2) patients with ARDS at enrollment (new global definition of ARDS in 2023); (3) pregnant, lactating or likely to be pregnant; (4) patients with chest trauma; (5) complicated with pneumonia or chronic lung diseases (such as COPD, asthma, etc.); (6) patients underwent surgery within 30 days before screening; (7) patients with expected survival less than 48 hours or life support restriction strategy; (8) patients receiving chemotherapy drugs or other immunomodulatory drugs (such as recombinant human granulocyte colony-stimulating factor, thymalfaxin, Xuebijing, ulinastatin, etc.); (9) significant abnormal liver function: baseline ALT or AST > 5×ULN, or total bilirubin (TBil) >=3×ULN, or acute liver failure; (10) use of methylprednisolone >=1mg/kg/ day (or equivalent dose of glucocorticoid) within 7 days before enrollment; (11) patients with baseline platelet count <50×10^9/L or active massive bleeding; (12) if the investigators considered that the safety risk of continuing the study was too high or that it was difficult to complete key assessments (13) patients (e.g., patients with psychiatric disorders) deemed by the investigator to be unsuitable for the study group.
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 ContactGuo Peng
Peking University People`s Hospital
Outcome results
None listed