Status:
COMPLETED
Three-Chamber Bags Retrospective Study in Spain
Lead Sponsor:
Fresenius Kabi
Conditions:
Parenteral Nutrition
Blood Stream Infection
Eligibility:
All Genders
18+ years
Brief Summary
The primary study objective is to assess the rates of blood stream infection (BSI) from the use of Three-Chamber Bags (e.g., SmofKabiven®, Kabiven®, others) compared to Hospital Compounded Bags (HCBs)...
Detailed Description
This is a retrospective observational database study of patients receiving parenteral nutrition (PN) for at least 3 consecutive days with hospital admission date between January 1, 2013, and December ...
Eligibility Criteria
Inclusion
- Adult hospital inpatients ≥ 18 years
- Treatment with PN for at least 3 consecutive days
- PN containing all three major macronutrients, delivered from 3CB or HCB
- Patients with hospital admission between January 1, 2013, and December 31, 2015 (study period)
Exclusion
- Bloodstream infection before or at the same day of first PN administration
- Immunosuppression due to concomitant therapy (e.g., immunosuppressive therapy due to transplantation, concomitant oral or intravenous administration of glucocorticoids) or disease (e.g., HIV, leukaemia)
- Permanent vascular access (port, shunts for dialysis)
- Femoral venous placement of central venous line used for PN
- Burns, extensive skin injuries (e.g., Lyell´s disease)
- Chemo-/radiotherapy for up to 3 months before hospital admission
- Change of PN bag type during observation period, e.g., from HCBs to 3CBs or vice-versa
Key Trial Info
Start Date :
December 14 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2019
Estimated Enrollment :
3723 Patients enrolled
Trial Details
Trial ID
NCT03284398
Start Date
December 14 2017
End Date
May 31 2019
Last Update
January 29 2021
Active Locations (2)
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1
Hospital de Manacor
Manacor, Balearic Islands, Spain, 7500
2
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041