An interventional study of Beta D Glucan test in Invasive Candidiases, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-21.
Sponsored by Medical University of Graz · Not applicable, Interventional, and Diagnostic
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 mucocutaneous infections and potentially fatal invasive infections of the bloodstream or organs. Throughout the past decades, invasive fungal infections (IFIs) are of increasing importance even in non-neutropenic patients who are in need of treatment in intensive care units (ICU) or have undergone major surgeries. Several factors like parenteral nutrition, central venous catheters, broad spectrum antibiotics admission, disturbance of gastrointestinal mucosa integrity have been associated with an increased incidence of IFIs. Positive testing for 1,3-ß-D-Glucan (BDG) in serum is widely used to assess invasive fungal infections. It detects circulating BDG, which is part of the fungal cell wall of clinical relevant fungi such as Candida spp. and Aspergillus spp..
The issue of BDG kinetics after intestinal mucosal damage (e.g. mucositis or gut surgery) is poorly understood. Intestinal mucosal damage is characterized by a loss of integrity of the intestinal mucosal barrier and increasing translocations of bacterial and/or fungal commensals of the gastrointestinal tract.
In abdominal surgery a key concern in serum BDG kinetics is the potential introduction of BDG from surgical sponges and gauze or mucosal damage due to surgical damage of the mucosal integrity. Compared to open abdominal surgery in laparoscopic abdominal surgery sponges and gauze are rarely used. As life-threatening intraabdominal candidiasis occurs in 30 to 40% of high-risk abdominal surgical intensive care unit (ICU) patients it is of utmost importance to obtain reliable BDG values for diagnosis or exclusion of invasive candidiasis.
65 studies on the registry are indexed under Candidiasis, Invasive; 6 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 47 interventional studies indexed under Candidiasis, Invasive.
Browse Candidiasis, Invasive studies →Medical University of Graz is the lead sponsor of 471 studies on the registry; 98 are open to participants now.
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Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Serial Beta D Glucan measurements in each patients before, during, and after surgery
Diagnostic Test: Beta D Glucan test
Measurement of BDG before, during and after surgery
Levels of Beta D Glucan after surgery
Measurement of Beta D Glucan after surgery in pg/ml
Time frame: after surgery up to day 5
Ran from Mar 2018 to primary completion in Jan 2019, 10 months.
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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