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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parenteral nutrition bag type | Groups with different parenteral nutrition bags (3CBs or HCBs) |
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| 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:
| Entire study period, from January 1, 2013 and December 31, 2015 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Manacor | Manacor | Balearic Islands | 7500 | Spain | ||
| Hospital Universitario 12 de Octubre |
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Retrospective cohort study. Data collection from medical records
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| ID | Title | Description |
|---|---|---|
| FG000 | Three-chambered Bag (3CB) | Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via an industrially-compounded three-chambered PN bag for ≥3 consecutive days during the study period |
| FG001 | Hospital-Compounded Bag (HCB) | Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via a Hospital-compounded all-in-one PN bag for ≥3 consecutive days during the study period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 5389 patient records were screened for eligibility; of these, 3723 met the selection criteria, including 2753 patients who received 3CB and 970 patients who received MCB
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| ID | Title | Description |
|---|---|---|
| BG000 | Three-Chambered Bag (3CB) | Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via industrially-compounded 3CB for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015). |
| BG001 | Hospital-compounded Bag (HCB) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| Posted | Count of Participants | Participants | Entire study period, from January 1, 2013 and December 31, 2015 |
|
Retrospective, observational, non-interventional study. All-cause mortality, Serious and Other (Not Including Serious) Adverse Events were not monitored/assessed
Not applicable since study was retrospective, observational/non-interventional. All-cause mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Three-Chambered Bag (3CB) | Not applicable (Observational/non-interventional retrospective data collection) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. med. Martin Westphal | Fresenius Kabi Deutschland, GmbH | +49 6172 686-7348 | martin.westphal@fresenius-kabi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2016 | Aug 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
| Madrid |
| 28041 |
| Spain |
Hospitalized adults (≥18 years) who received PN containing all three major macronutrients via hospital-compounded all-in-one bag for ≥3 consecutive days during the observation period (January 1, 2013 to December 31, 2015). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Hospital-compounded Bag |
Treatment with Hospital-compounded PN bag |
|
|
| Secondary | Sepsis During PN | Percentage of patients presenting at least one episode of Sepsis during treatment with PN for each group (3CB vs HCB) | Posted | Count of Participants | Participants | 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) | Posted | Count of Participants | Participants | Any day during PN treatment |
|
|
|
| Secondary | Use of Vasopressor Treatment | Percentages of patients requiring vasopressor support during PN treatment | Posted | Count of Participants | Participants | 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) | Posted | Count of Participants | Participants | 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) | Posted | Count of Participants | Participants | 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) | Simultaneous occurring laboratory abnormalities | Posted | Count of Participants | Participants | 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) | Posted | Count of Participants | Participants | 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) | Posted | Number | Days | 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) | Posted | Number | Days | All patients admitted in the ICU at any time during PN treatment |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Hospital-compounded Bag (HCB) | Not applicable (Observational/non-interventional retrospective data collection) | 0 | 0 | 0 | 0 | 0 | 0 |
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| Any abnormal electrolytes |
|
| Multiple organ failure |
|