Three-Chamber Bags Retrospective Study in Spain

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

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.

Study Overview

• Status: Completed
• Conditions: Parenteral Nutrition; Blood Stream Infection

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.

• Study Type: Observational
• Enrollment (Actual): 3723

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Islas Baleares
    • Manacor, Islas Baleares, Spain, 7500
      • Hospital de Manacor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Parenteral nutrition bag type; 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

Collaborators and Investigators

• Sponsor: Fresenius Kabi
• Investigators: Study Chair: John F Stover, Fresenius Kabi Deutschland GmbH, Borkenberg 14, 61440 Oberursel, Germany; Principal Investigator: Juan Carlos M González, Hospital Universitario 12 de Octubre, 28041 Madrid, Spain

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 14, 2017
• Primary Completion (ACTUAL): May 31, 2019
• Study Completion (ACTUAL): May 31, 2019

Study Registration Dates

• First Submitted: September 4, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (ACTUAL): September 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: ICU; BSI; computerized; parenteral nutrition; 3-chamber bags; ICD-9-CM; Medical records system
• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Infections
• Other Study ID Numbers: 3CBs-001-CNI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No