Three-Chamber Bags Retrospective Study in Spain

Fresenius Kabi

Status: Completed

Conditions: Blood Stream Infection; Parenteral Nutrition

Study type: Observational

Funder types: Industry

Identifiers

NCT03284398

3CBs-001-CNI

Details and patient eligibility

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.

Full 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 31, 2015 (study period).

The study will use an as treated approach, where patients will be followed from the index date (hospital admission day of the hospitalization during which PN is administered) up to patient discharge or death (observation period).

The study will be conducted using an initial EMR (Electronic Medical Record) data retrieval process, followed by manual data retrieval (chart review) that will complement data obtained from EMR. Data collection for manual data retrieval will be conducted through an eCRF.

The documentation of patient data will comprise two sequential steps. The initial step will include data of 30% of patients and then an interim analysis (IA) will be conducted. If IA shows positive results, data for the remaining 70% of patients (step II) will be gathered.

The study will be conducted in 10-14 sites in Spain.

Data analysis: Baseline demographics, co-morbidities, and hospitalization characteristics will be reported descriptively by means of mean with standard deviations and medians with ranges for continuous variables and by counts and percentages for categorical variables. Incidence rates for BSI will be reported by treatment group.

Enrollment: 3,723 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

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

Trial design

3,723 participants in 1 patient group

Parenteral nutrition bag type

Description:

Groups with different parenteral nutrition bags (3CBs or HCBs)