Three-Chamber Bags Retrospective Study in Spain

Parenteral Nutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284398
• Other study ID #: 3CBs-001-CNI
• Status: Completed
• Start date: December 14, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: January 2021
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 3723
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Stream Infection
• Infection
• Parenteral Nutrition

Locations

Country	Name	City	State
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital de Manacor	Manacor	Islas Baleares

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Use of Vasopressor Treatment	Percentages of patients requiring vasopressor support during PN treatment	Patients requiring vasopressor support at any time during treatment with PN
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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