Three-Chamber Bags Retrospective Study in Spain

NCT ID: NCT03284398

Last Updated: 2021-01-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3723 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-14
• Study Completion Date: 2019-05-31

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.

Conditions

Parenteral Nutrition; Blood Stream Infection

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Parenteral nutrition bag type

Groups with different parenteral nutrition bags (3CBs or HCBs)

No interventions assigned to this 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Kabi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John F Stover

Role: STUDY_CHAIR

Fresenius Kabi Deutschland GmbH, Borkenberg 14, 61440 Oberursel, Germany

Juan Carlos M González

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario 12 de Octubre, 28041 Madrid, Spain

Locations

Hospital de Manacor

Manacor, Balearic Islands, Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

3CBs-001-CNI

Identifier Type: -

Identifier Source: org_study_id