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Three-Chamber Bags Retrospective Study in Spain

Sponsored by Fresenius Kabi

About this trial

Last updated 4 years ago

Study ID

3CBs-001-CNI

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 6 years ago

What is this trial about?

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) in patients requiring parenteral nutrition in Spanish hospitals.

What are the participation requirements?

Yes

Inclusion Criteria

1. Adult hospital inpatients ≥ 18 years

2. Treatment with PN for at least 3 consecutive days

3. PN containing all three major macronutrients, delivered from 3CB or HCB

4. Patients with hospital admission between January 1, 2013, and December 31, 2015 (study period)

No

Exclusion Criteria

1. Bloodstream infection before or at the same day of first PN administration

2. 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)

3. Permanent vascular access (port, shunts for dialysis)

4. Femoral venous placement of central venous line used for PN

5. Burns, extensive skin injuries (e.g., Lyell´s disease)

6. Chemo-/radiotherapy for up to 3 months before hospital admission

7. Change of PN bag type during observation period, e.g., from HCBs to 3CBs or vice-versa