Three-Chamber Bags Retrospective Study in Spain

Completed

Conditions: Parenteral Nutrition
Blood Stream Infection

Registration Number: NCT03284398

Lead Sponsor: Fresenius Kabi

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3723

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB)	Entire study period, from January 1, 2013 and December 31, 2015	Confirmation of BSI required fulfillment of all of the following criteria: * International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) code for sepsis (038.x), septicemia (995.91), severe sepsis (995.92), septic shock (785.52), bacteremia (790.7), unspecified infection due to central venous catheter (999.31), or BSI due to central venous catheter (999.32) * Positive blood culture collected during PN administration * Concomitant antimicrobial therapy

Secondary Outcome Measures

Name	Time	Method
Treatment With Antimicrobials During PN	Any day during PN treatment	Percentage of patients receiving antimicrobial agents during treatment with PN for each group (3CB vs HCB)
Use of Vasopressor Treatment	Patients requiring vasopressor support at any time during treatment with PN	Percentages of patients requiring vasopressor support during PN treatment
Length of Stay in the ICU	All patients admitted in the ICU at any time during PN treatment	Total number of days in the ICU for each group (3CB vs HCB)
Hospital Length of Stay (LOS)	Duration in days from admission to death or discharge for each treatment arm	Hospital length of stay in days for patients for each group (3CB vs HCB)
Organ Failure	Any time during PN treatment	Percentage of patients presenting at least one organ failure during treatment with PN for each group (3CB vs HCB)
Sepsis During PN	From date of admission to date of discharge	Percentage of patients presenting at least one episode of Sepsis during treatment with PN for each group (3CB vs HCB)
Use of Mechanical Ventilation	Patients requiring mechanical ventilation at any time during PN treatment	Percentage of patients requiring mechanical ventilation during PN treatment for each group (3CB vs HCB)
Renal Replacement Therapy	Patients requiring renal replacement therapy for at least one day during PN treatment	Percentage of patients requiring Renal Replacement Therapy during PN treatment for each group (3CB vs HCB)
Newly-occurred Abnormal Laboratory Findings During PN	During PN treatment inclusive day 1	Percentage of patients presenting newly-occurred abnormal laboratory results during PN for each group (3CB vs HCB)