Three-Chamber Bags Retrospective Study in Spain

Study Overview
=================
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.

Official Title
-----------------
Observational Retrospective Analysis Assessing the Influence of Three-Chamber Bags Compared to Hospital Compounded Parenteral Nutrition Bags on Blood Stream Infections

Conditions
-----------------
Parenteral Nutrition, Blood Stream Infection

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parenteral nutrition bag type<br>Groups with different parenteral nutrition bags (3CBs or HCBs) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Entire study period, from January 1, 2013 and December 31, 2015 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sepsis During PN | Percentage of patients presenting at least one episode of Sepsis during treatment with PN for each group (3CB vs HCB) | 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) | Any day during PN treatment | 
| Use of Vasopressor Treatment | Percentages of patients requiring vasopressor support during PN treatment | 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) | 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) | Patients requiring renal replacement therapy for at least one day during PN treatment | 
| Newly-occurred Abnormal Laboratory Findings During PN | Percentage of patients presenting newly-occurred abnormal laboratory results during PN for each group (3CB vs HCB) | During PN treatment inclusive day 1 | 
| Organ Failure | Percentage of patients presenting at least one organ failure during treatment with PN for each group (3CB vs HCB) | Any time during PN treatment | 
| Hospital Length of Stay (LOS) | Hospital length of stay in days for patients for each group (3CB vs HCB) | Duration in days from admission to death or discharge for each treatment arm | 
| Length of Stay in the ICU | Total number of days in the ICU for each group (3CB vs HCB) | All patients admitted in the ICU at any time during PN treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU, parenteral nutrition, 3-chamber bags, ICD-9-CM, BSI, Medical records system, computerized