Back to resultsthe Influence of Prophylactic and Empirical Anti-fungal Treatment in Severe Sepsis Patients With Perforations
Primary Purpose
Intra-abdominal Perforation
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
fluconazole and caspofungin
Sponsored by
About this trial
This is an interventional prevention trial for Intra-abdominal Perforation focused on measuring severe sepsis, intra-abdominal perforation, surgical intensive care unit, fungal infection, prophylactic anti-fungal treatment
Eligibility Criteria
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. -
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Prophylactic group
Empirical group
Arm Description
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.
Outcomes
Primary Outcome Measures
all cause mortality
Secondary Outcome Measures
fungal infection
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.
Full Information
NCT ID
NCT02941068
First Posted
October 15, 2016
Last Updated
October 19, 2016
Sponsor
Nanjing PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02941068
Brief Title
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
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing PLA General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intra-abdominal Perforation
Keywords
severe sepsis, intra-abdominal perforation, surgical intensive care unit, fungal infection, prophylactic anti-fungal treatment
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
223 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prophylactic group
Arm Type
Experimental
Arm Description
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.
Arm Title
Empirical group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
fluconazole and caspofungin
Primary Outcome Measure Information:
Title
all cause mortality
Time Frame
six months
Secondary Outcome Measure Information:
Title
fungal infection
Description
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.
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
gao tao, ph.d
Organizational Affiliation
Nanjing PLA General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
cao chun, ph.d
Organizational Affiliation
Nanjing PLA General Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
shi jialiang, ph.d
Organizational Affiliation
Nanjing PLA General Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16505648
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.
Results Reference
result
PubMed Identifier
19172247
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.
Results Reference
result
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the Influence of Prophylactic and Empirical Anti-fungal Treatment in Severe Sepsis Patients With Perforations
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