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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intra-abdominal Perforation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prophylactic group

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.

Group Type EXPERIMENTAL

fluconazole and caspofungin

Intervention Type DRUG

Empirical group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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fluconazole and caspofungin

Intervention Type DRUG

Eligibility Criteria

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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. -

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No