Three-Chamber Bags Retrospective Study in Spain

Fresenius Kabi3,723 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

3,723

Conditions

Parenteral Nutrition Blood Stream Infection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Hospital de Manacor

Manacor, Balearic Islands, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Outcomes

Primary Outcomes

Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB)

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

Time frame: Entire study period, from January 1, 2013 and December 31, 2015

Secondary Outcomes

Sepsis During PN

Percentage of patients presenting at least one episode of Sepsis during treatment with PN for each group (3CB vs HCB)

Time frame: From date of admission to date of discharge

Treatment With Antimicrobials During PN

Percentage of patients receiving antimicrobial agents during treatment with PN for each group (3CB vs HCB)

Time frame: Any day during PN treatment

Use of Vasopressor Treatment

Percentages of patients requiring vasopressor support during PN treatment

Time frame: Patients requiring vasopressor support at any time during treatment with PN

Use of Mechanical Ventilation

Percentage of patients requiring mechanical ventilation during PN treatment for each group (3CB vs HCB)

Time frame: Patients requiring mechanical ventilation at any time during PN treatment

Renal Replacement Therapy

Percentage of patients requiring Renal Replacement Therapy during PN treatment for each group (3CB vs HCB)

Data from ClinicalTrials.gov

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