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

Phase 2

Completed

• Conditions: Intra-abdominal Perforation
• Interventions: Drug: fluconazole and caspofungin

• Registration Number: NCT02941068
• Lead Sponsor: Nanjing PLA General Hospital

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.

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2016-06
• Status Verified: 2016-10
• Study First Submitted: 2016-10-15
• Study First Submitted QC: 2016-10-19
• Last Update Submitted: 2016-10-19
• Study First Posted: 2016-10-21
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prophylactic group	fluconazole and caspofungin	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.

Primary Outcome Measures

Name	Time	Method
all cause mortality	six months

Secondary Outcome Measures

Name	Time	Method
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.