Intra-abdominal Perforation
Conditions
Keywords
severe sepsis, intra-abdominal perforation, surgical intensive care unit, fungal infection, prophylactic anti-fungal treatment
Brief summary
This prospective intended to observe the influence of prophylactic and empirical anti-fungal treatment on Severe Sepsis patients with perforations. With the consent of patients' legal guardian for prophylactic use of antifungal agents, patients were divided into two groups: prophylactic group and Empirical group.
Detailed description
Intra-abdominal perforation is the high risk of fungal infection. The flora in digestive tract would colonize and go to the blood to develop severe bacteria and fungal infection in intra-abdominal perforation and about one-third of patients with gastrointestinal perforations or anastomotic leakages in ICU develop intra-abdominal fungal infection. In particular, the severe sepsis arisen from these infections could further increase the mortality. However, empiric/preemptive treatment in most studies failed to improve the prognosis and few of the studies that addressed the influence of prophylactic anti-fungal treatment in patients with GI Perforation.
Interventions
DRUGfluconazole and caspofungin
Sponsors
Nanjing PLA General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age ≥16 years 2. the time between gastrointestinal perforations or anastopmotic leakage(s) after abdominal surgery and entering ICU within 6 hours 3. ICU stay of at least 5 days 4. APACHE Ⅱ score within 24 hours of randomization of 16 or more 5. severe sepsis 6. written informed consent -
Exclusion criteria
1. documented fungus before gastrointestinal perforations/anastopmotic leakage(s) ongoing antifungal treatment before the study; 2. fluconazole/caspofungin allergy; 3. pregnant of lactating woman; 4. life expectancy of 48 hours or less. -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all cause mortality | six months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fungal infection | six months | An blood specimen and abdominal drainage fluids if available were obtained for microbiological culture at the time of the gastrointestinal perforations and intra-abdominal specimen was collected at the time of the immediately surgery. All specimens were also obtained 1st, 3rd, 5th, 7th day after perforations and thereafter at 3 days intervals. |
Outcome results
None listed