Clinical trial NCT02941068: the Influence of Prophylactic and Empirical Anti-fungal Treatment in Severe Sepsis Patients With Perforations
Official title: Prophylactic Annti-fungal Treatment in Severe Sepsis Patients With Perforations in SICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intra-abdominal Perforation
Keywords: severe sepsis
intra-abdominal perforation
surgical intensive care unit
fungal infection
prophylactic anti-fungal treatment
Lead sponsor: Nanjing PLA General Hospital
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 223
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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. -

Primary outcomes:
measure: all cause mortality
timeFrame: six months
Secondary outcomes:
measure: fungal infection
timeFrame: six months
Other outcomes:
Locations:
Study officials:
affiliation: Nanjing PLA General Hospital
name: gao tao, ph.d
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanjing PLA General Hospital
name: cao chun, ph.d
role: STUDY_DIRECTOR
affiliation: Nanjing PLA General Hospital
name: shi jialiang, ph.d
role: PRINCIPAL_INVESTIGATOR
References:
citation: Montravers P, Dupont H, Gauzit R, Veber B, Auboyer C, Blin P, Hennequin C, Martin C. Candida as a risk factor for mortality in peritonitis. Crit Care Med. 2006 Mar;34(3):646-52. doi: 10.1097/01.CCM.0000201889.39443.D2.
citation: Senn L, Eggimann P, Ksontini R, Pascual A, Demartines N, Bille J, Calandra T, Marchetti O. Caspofungin for prevention of intra-abdominal candidiasis in high-risk surgical patients. Intensive Care Med. 2009 May;35(5):903-8. doi: 10.1007/s00134-009-1405-8. Epub 2009 Jan 27.