Three-Chamber Bags Retrospective Study in Spain

NCT03284398 | Completed Results

• 1 other identifier: 3CBs-001-CNI
• Study Type: observational
• Target: 3,723
• Locations: 1 country
• Sites: 2

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.

Conditions

Parenteral Nutrition; Blood Stream Infection

Keywords

parenteral nutrition; ICU; 3-chamber bags; ICD-9-CM; BSI; Medical records system; computerized

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Sepsis During PN

  From date of admission to date of discharge

• Treatment With Antimicrobials During PN

  Any day during PN treatment

• Use of Vasopressor Treatment

  Patients requiring vasopressor support at any time during treatment with PN

• Use of Mechanical Ventilation

  Patients requiring mechanical ventilation at any time during PN treatment

• Renal Replacement Therapy

  Patients requiring renal replacement therapy for at least one day during PN treatment

Study Arms (1)

Parenteral nutrition bag type

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

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Kabi: lead

Study Sites (2)

Hospital de Manacor

Manacor, Balearic Islands, 7500, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Prof. Dr. med. Martin Westphal
• Organization: Fresenius Kabi Deutschland, GmbH

martin.westphal@fresenius-kabi.com

+49 6172 686-7348

Study Officials

• John F Stover

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

  STUDY CHAIR

• Juan Carlos M González

  Hospital Universitario 12 de Octubre, 28041 Madrid, Spain

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 15, 2017
• Study Start: December 14, 2017
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: January 29, 2021
• Results First Posted: January 8, 2021

Record last verified: 2021-01

Locations

ES (2)