N/A
N=3,723
Three-Chamber Bags Retrospective Study in Spain
Parenteral Nutrition · Blood Stream Infection
Bottom Line
View on ClinicalTrials.gov: NCT03284398 ↗Enrolled (actual)
3,723
Serious AEs
—
Results posted
Jan 2021
Primary outcome: Primary: Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB) — 127; 106 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fresenius Kabi
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB) |
127; 106 | — |
| SECONDARY Sepsis During PN |
431; 228 | — |
| SECONDARY Treatment With Antimicrobials During PN |
831; 370 | — |
| SECONDARY Use of Vasopressor Treatment |
410; 291 | — |
| SECONDARY Use of Mechanical Ventilation |
410; 299 | — |
| SECONDARY Renal Replacement Therapy |
78; 89 | — |
| SECONDARY Newly-occurred Abnormal Laboratory Findings During PN |
1193; 584; 1414; 651; 1444; 699 | — |
| SECONDARY Organ Failure |
905; 562; 593; 255; 312; 307 | — |
| SECONDARY Hospital Length of Stay (LOS) |
26,601; 30,384 | — |
| SECONDARY Length of Stay in the ICU |
3,017; 3,772 | — |
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) in patients requiring parenteral nutrition in Spanish hospitals.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03284398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.