NCT02941068

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: Nanjing PLA General Hospital · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intra-abdominal Perforation

Interventions

Type	Name	Description
DRUG	fluconazole and caspofungin

Timeline

• Start date: 2012-03-01
• Primary completion: 2016-06-01
• First posted: 2016-10-21
• Last updated: 2016-10-21