An interventional study of Taurolidine and Physiologic Serum in Sepsis, sponsored by University Hospital, Rouen. Terminated at 7 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-03-05.
Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Prevention
Home parenteral nutrition (HPN) is a validated technique for patients with various intestinal disease leading to chronic malabsorption or obstruction, whatever the aetiology. Intravascular catheter-related bloodstream infections (CRBSI) is the more frequent complication of patients with HPN and an important cause of morbidity and mortality in these patients. Moreover, CRBSI often recur after a first treatment of the catheter with a combination of an antibiotic lock on the catheter and systemic intravenous antibiotics. In more than 50 % of the cases, another CRBSI will occur in a median delay of 5 months.
The aim of the study is to evaluate the efficacy of a taurolidine lock secondary prophylaxis on CRBSI recurrence in HPN patients.
Study population is separated in 2 groups, the first one receiving the Taurolock and the second one receiving a placebo. This is a randomized double-blind six-month study.
1,894 studies on the registry are indexed under Sepsis; 458 are open to participants now.
This study's enrollment of 39 is below the median of 105 across 893 interventional studies indexed under Sepsis.
Browse Sepsis studies →University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Use of taurolidine in prevention of bloodstream infection related to central venous access
Device: Taurolidine
Use of Physiologic Serum to compare to arm A
Device: Physiologic Serum
2 mL of taurolidine instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months
2 mL of physiologic serum instillate on the intravascular catheter after each parenteral nutrition session for a duration of 6 months
Number of recurrence of catheter-related infection in each group
Time frame: 6 months
This study is terminated, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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University Hospital, Rouen