None listed
Conditions
Brief summary
Peritonitis is one of the most important etiologies resulting in abdominal sepsis leading to considerable morbidity and mortality. However, there is still no adequate evidence-based data about the optimal duration of antibiotics (AB) treatment for moderate to severe complicated intra-abdominal infections after abdominal surgery. Prolonged duration of AB therapy can increase the risk of developing multidrug-resistant strains as well as adverse effects of AB and treatment associated costs. A systematic review showed that procalcitonin (PCT) levels were more sensitive and more specific than C-reactive protein (CRP) levels for differentiating bacterial from non-infective causes of inflammation. PCT improves the clinical diagnosis of sepsis in critically-ill patients and patients with community-acquired pneumonia. In patients with lower respiratory tract infections, a strategy of PCT guidance AB therapy compared with standard guidelines resulted in similar rates of adverse outcomes, as well as lower rates of antibiotic exposure and AB-associated adverse effects. Some small studies in surgical intensive unit demonstrated that PCT-based algorithms may reduce AB exposure without compromising clinical outcomes. We design this pilot study to investigate the feasibility and safety of PCT-based algorithms to guide post-operative AB therapy in secondary peritonitis. We will prospectively enroll 30 patients in this study for one year period. Appropriate historical control of the same kind of patients will be collected from hospital based databases. To investigate predictive and prognostic value of novel biomarkers, we will also explore the potential biomarkers of sepsis including plasma gelsolin and sphingolipids using liquid chromatography coupled tandem mass spectrometry method. In this study, we expect to shorten and optimize the duration of AB therapy in secondary peritonitis after surgery without compromising clinical outcomes, provide more information about novel biomarkers, and provide standardized proteomic methods to detect them.
Interventions
Treatment plan:
All patients who fulfill the inclusion/exclusion criteria will receive empiric antibiotics treatment (rocephin 1gram intravenous given every 12 hours and metronidazole 500mg intravenous infusion every 8 hours) pre-operation and immediately post-operation. Infection specialists blinded to this project will routinely review the justification of antibiotics treatment including choices and duration in every patient. The in-charge physicians will decide whether to discontinue antibiot
Treatment plan: All patients who fulfill the inclusion/exclusion criteria will receive empiric antibiotics treatment (rocephin 1gram intravenous given every 12 hours and metronidazole 500mg intravenous infusion every 8 hours) pre-operation and immediately post-operation. Infection specialists blinded to this project will routinely review the justification of antibiotics treatment including choices and duration in every patient. The in-charge physicians will decide whether to discontinue antibiotics according to the algorithm and clinical conditions or extend the antibiotics treatment if clinically needed. PCT algorithm: Antibiotic treatment will be discontinued if clinical signs of infection improved and the PCT value is either <1.0 ng/ml or decreases to less than 80% of the peak post-operative concentration over 3 postoperative days. PCT and biomarkers measurement: PCT levels will be obtained pre-operation, post-operative day1, 3, 5, 7, and before discharge by central lab in Chang-Gung Memorial Hospital (CGMH)-Keelung branch. The additional levels will be ordered by physicians after one week if clinically needed. Besides, plasma samples drawn by patients on pre-operation, post-operative day1, 3, 5, 7, and before discharge will be stored until analysis of liquid chromatography coupled tandem mass spectrometry (LC-MS/MS). PCT-assays Measuring Range: The BRAHMS PCT KRYPTOR assay measures concentrations between 0.02 and 5000 ng/ml (0.02 to 50 ng/ml directly and up to 5000 ng/ml after sample dilution). Precision: BRAHMS PCT KRYPTOR shows a high precision in the determination of serum/plasma PCT concentrations. The intra-assay CV and the inter-assay CV are 2-3% on the whole PCT concentration range.
Sponsors
Chang Gung Memorial Hospital, Keelung
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients more than 20 years old who will receive emergency abdominal operations with sepsis due to secondary peritonitis are eligible for enrollment.
Exclusion criteria
Patients who meet one or more of the following criteria will be excluded: (a) patients who are moribund (life expectance not expected to be > 72 hours because of imminent death) (b) patients with liver cirrhosis, Child’s class B and C liver disease (c) patients with profound septic shock under treatment of high dose inotropic agents (d) pre-existing infection underwent antibiotics treatment (e) multiple traumatized patients with unstable hemodynamic status (f) patients or their family will not participate in this study (g) immunocompromised patients such as HIV infection, long term steroids treatment, post-chemotherapy (h) pregnant women.
Outcome results
None listed