Sepsis requiring emergency abdominal surgery to remove the infection
Conditions
Interventions
Experimental group:SuccinylatedGelatin, Multiple Electrolytes and Sodium Acetate Injection
Control Group:Acetated ringer's solution
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years old; 2.Abdominal infection diagnosed as sepsis according to Sepsis-3; 3.Emergency surgery to remove the lesion is required due to the condition; 4.SOFA score >= 2 points and blood lactate > 2 mmol/L at enrollment; 5.The subject or his/her guardian can understand the purpose of the trial, voluntarily participate and sign the informed consent;
Exclusion criteria
Exclusion criteria: 1.Any use of artificial colloids within 24 hours prior to randomization; 2.Expected death within 48 hours (ASA grade >= V). 3.Atrial fibrillation or congestive heart failure. 4.Severe respiratory distress ARDS. 5.Preoperative coagulation disorder or receiving anticoagulant therapy. 6.Preoperative need for renal support (long-term or intermittent treatment, including hemodialysis or peritoneal dialysis). 7.Acute burns exceeding 10% of body surface area. 8.Severe liver damage. 9.Severe electrolyte imbalance. 10.Pregnant or lactating women. 11.Known allergy to gelatin. 12.Participating in other interventional clinical trials. 13.The researcher believes that the patient has other conditions that are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fluid Balance;Proportion of patients achieving hemodynamic stability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Respiratory Complications;Neurological Function & Quality of Life;Incidence of Cardiovascular Complications;Study Drug Utilization Intensity;All-Cause Mortality;ICU Length of Stay, ICU-LOS;Blood Product Utilization Rate;Internal Environment Monitoring Parameters;Vasoactive Drug Load;Inotropic Drug Utilization Rate;Lactate Reduction Magnitude;Capillary Refill Time Normalization Rate;Incidence of Renal Complications;Sublingual Microcirculation;Proportion of Patients with SOFA Score Improvement;Circulating Biomarkers;Proportion of Patients with Severe Organ Dysfunction;Ventilator-Free Time, VFT;Acute Kidney Injury Incidence (AKI Incidence);Coagulopathy Incidence;Gastrointestinal Function Recovery;Vasoactive Drug-Free Time;Incidence of Perioperative Fluid Overload;Cumulative Days of Renal Replacement Therapy, RRT;Hospital Length of Stay, H-LOS; | — |
Countries
China
Contacts
Public ContactChanghong Miao
Zhongshan Hospital, Fudan University
Outcome results
None listed