Clinical trial NCT03284398: Three-Chamber Bags Retrospective Study in Spain
Official title: Observational Retrospective Analysis Assessing the Influence of Three-Chamber Bags Compared to Hospital Compounded Parenteral Nutrition Bags on Blood Stream Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parenteral Nutrition
Blood Stream Infection
Keywords: parenteral nutrition
ICU
3-chamber bags
ICD-9-CM
BSI
Medical records system
computerized
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2017-09-15
Enrollment: 3723
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population will include adult hospitalized patients receiving PN, treated on any ward and by any medical discipline within the hospital (e.g., intensive care unit, normal wards; surgery, non-surgery) during the study period. For every patient, one hospitalization episode will be documented.

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) in patients requiring parenteral nutrition in Spanish hospitals.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB)
timeFrame: Entire study period, from January 1, 2013 and December 31, 2015
Secondary outcomes:
measure: Sepsis During PN
timeFrame: From date of admission to date of discharge
measure: Treatment With Antimicrobials During PN
timeFrame: Any day during PN treatment
measure: Use of Vasopressor Treatment
timeFrame: Patients requiring vasopressor support at any time during treatment with PN
measure: Use of Mechanical Ventilation
timeFrame: Patients requiring mechanical ventilation at any time during PN treatment
measure: Renal Replacement Therapy
timeFrame: Patients requiring renal replacement therapy for at least one day during PN treatment
measure: Newly-occurred Abnormal Laboratory Findings During PN
timeFrame: During PN treatment inclusive day 1
measure: Organ Failure
timeFrame: Any time during PN treatment
measure: Hospital Length of Stay (LOS)
timeFrame: Duration in days from admission to death or discharge for each treatment arm
measure: Length of Stay in the ICU
timeFrame: All patients admitted in the ICU at any time during PN treatment
Other outcomes:
Locations:
city: Manacor
country: Spain
facility: Hospital de Manacor
state: Islas Baleares
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Fresenius Kabi Deutschland GmbH, Borkenberg 14, 61440 Oberursel, Germany
name: John F Stover
role: STUDY_CHAIR
affiliation: Hospital Universitario 12 de Octubre, 28041 Madrid, Spain
name: Juan Carlos M González
role: PRINCIPAL_INVESTIGATOR
References: