the Influence of Prophylactic and Empirical Anti-fungal Treatment in Severe Sepsis Patients With Perforations

Study Overview
=================
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.

Official Title
-----------------
Prophylactic Annti-fungal Treatment in Severe Sepsis Patients With Perforations in SICU

Conditions
-----------------
Intra-abdominal Perforation

Intervention / Treatment
-----------------
* Drug: fluconazole and caspofungin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥16 years the time between gastrointestinal perforations or anastopmotic leakage(s) after abdominal surgery and entering ICU within 6 hours ICU stay of at least 5 days APACHE Ⅱ score within 24 hours of randomization of 16 or more severe sepsis written informed consent - Exclusion Criteria: documented fungus before gastrointestinal perforations/anastopmotic leakage(s) ongoing antifungal treatment before the study; fluconazole/caspofungin allergy; pregnant of lactating woman; life expectancy of 48 hours or less. -

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prophylactic group<br>Patients would received intravenous fluconazole (loading dose 800 mg, then 400 mg/day) or caspofungin (loading dose 70 mg, then 50 mg/day) if patients had organ failure or renal or liver dysfunction during the immediately surgery. The antifungal treatment would continue for 5 to 7 days. | Drug: fluconazole and caspofungin<br> <br> |
| No Intervention: Empirical group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fungal infection | 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. | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
severe sepsis, intra-abdominal perforation, surgical intensive care unit, fungal infection, prophylactic anti-fungal treatment