Status:

COMPLETED

Influence of Open and Laparoscopic Abdominal Surgery Involving the Intestinal Tract on Serum 1,3-ß-D-Glucan (BDG) Values

Lead Sponsor:

Medical University of Graz

Collaborating Sponsors:

Barmherzige Brueder Marschallgasse / Graz

Conditions:

Invasive Candidiases

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Candida species are both known to colonize physiologically mucosal surfaces in the human body without causing signs or symptoms of infection and to cause a wide variety of diseases, including mucocuta...

Eligibility Criteria

Inclusion

  • Elective open abdominal surgery involving the small and/or large colon and with surgical sectioning of intestinal mucosa
  • Signed informed consent

Exclusion

  • Ongoing antifungal therapy for treatment of active fungal infection or antifungal therapy within 4 weeks prior to inclusion
  • Antibiotic therapy other than optional single shot surgical prophylaxis as clinically indicated
  • Ongoing Enterococcus sp. bacteremia or treatment of Enterococcus sp. bacteremia within 4 weeks prior to inclusion
  • Clinical or radiological or laboratory evidence of current infectious disease (i.e. temperature \>38°C, elevated C-reactive protein (CRP) \>5mg/dl, leukocytosis \>11400/μl, elevated neutrophiles \>78%) as assessed by the treating physician
  • Immunoglobulin, blood or blood products (i.e. thrombocytes, fresh frozen plasma) administration within 4 weeks prior to inclusion
  • Abdominal surgery (laparoscopic or open) or other major surgeries (e.g. aortocoronary bypass) within 4 weeks prior to inclusion
  • Subsequent invasive candidiasis (defined according to proposed European Organization for Research and Treatment of Cancer Mycoses study group \[EORTC/MSG\] definitions of fungal infections in ICU) or other complicating infectious disease after surgery within the 5 day observation time frame

Key Trial Info

Start Date :

March 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 17 2019

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT03468803

Start Date

March 1 2018

End Date

January 17 2019

Last Update

March 21 2019

Active Locations (1)

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Medical University of Graz

Graz, Stmk, Austria, 8036