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

Sponsor

Nanjing PLA General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02941068

Collaborator

(none)

223

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intra-abdominal Perforation	Drug: fluconazole and caspofungin	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

223 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: fluconazole and caspofungin
No Intervention: Empirical group

Arm

Intervention/Treatment

Experimental: 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.

Drug: fluconazole and caspofungin

No Intervention: Empirical group

Outcome Measures

Primary Outcome Measures

all cause mortality [six months]

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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. -