Blood Stream Infection, Parenteral Nutrition
Conditions
Keywords
parenteral nutrition, ICU, 3-chamber bags, ICD-9-CM, BSI, Medical records system, computerized
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.
Interventions
None listed
Sponsors
Fresenius Kabi
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB) | Entire study period, from January 1, 2013 and December 31, 2015 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment With Antimicrobials During PN | Any day during PN treatment | Percentage of patients receiving antimicrobial agents during treatment with PN for each group (3CB vs HCB) |
| Use of Vasopressor Treatment | Patients requiring vasopressor support at any time during treatment with PN | Percentages of patients requiring vasopressor support during PN treatment |
| Use of Mechanical Ventilation | Patients requiring mechanical ventilation at any time during PN treatment | Percentage of patients requiring mechanical ventilation during PN treatment for each group (3CB vs HCB) |
| Renal Replacement Therapy | Patients requiring renal replacement therapy for at least one day during PN treatment | Percentage of patients requiring Renal Replacement Therapy during PN treatment for each group (3CB vs HCB) |
| Sepsis During PN | From date of admission to date of discharge | Percentage of patients presenting at least one episode of Sepsis during treatment with PN for each group (3CB vs HCB) |
| Organ Failure | Any time during PN treatment | Percentage of patients presenting at least one organ failure during treatment with PN for each group (3CB vs HCB) |
| Hospital Length of Stay (LOS) | Duration in days from admission to death or discharge for each treatment arm | Hospital length of stay in days for patients for each group (3CB vs HCB) |
| Length of Stay in the ICU | All patients admitted in the ICU at any time during PN treatment | Total number of days in the ICU for each group (3CB vs HCB) |
| Newly-occurred Abnormal Laboratory Findings During PN | During PN treatment inclusive day 1 | Percentage of patients presenting newly-occurred abnormal laboratory results during PN for each group (3CB vs HCB) |
Countries
Spain
Participant flow
Recruitment details
Retrospective cohort study. Data collection from medical records
Participants by arm
| Arm | Count |
|---|---|
| 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). | 2,753 |
| Hospital-compounded Bag (HCB) 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). | 970 |
| Total | 3,723 |
Baseline characteristics
| Characteristic | Hospital-compounded Bag (HCB) | Total | Three-Chambered Bag (3CB) |
|---|---|---|---|
| Age, Continuous | 66.5 years STANDARD_DEVIATION 14.8 | 66.8 years STANDARD_DEVIATION 15.2 | 66.8 years STANDARD_DEVIATION 15.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Spain | 970 participants | 3723 participants | 2753 participants |
| Sex: Female, Male Female | 354 Participants | 1498 Participants | 1144 Participants |
| Sex: Female, Male Male | 616 Participants | 2225 Participants | 1609 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: Entire study period, from January 1, 2013 and December 31, 2015
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Three-Chambered Bag | Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB) | 127 Participants |
| Hospital-compounded Bag | Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB) | 106 Participants |
Secondary
Hospital Length of Stay (LOS)
Hospital length of stay in days for patients for each group (3CB vs HCB)
Time frame: Duration in days from admission to death or discharge for each treatment arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Three-Chambered Bag | Hospital Length of Stay (LOS) | 26,601 Days |
| Hospital-compounded Bag | Hospital Length of Stay (LOS) | 30,384 Days |
Secondary
Length of Stay in the ICU
Total number of days in the ICU for each group (3CB vs HCB)
Time frame: All patients admitted in the ICU at any time during PN treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Three-Chambered Bag | Length of Stay in the ICU | 3,017 Days |
| Hospital-compounded Bag | Length of Stay in the ICU | 3,772 Days |
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)
Time frame: During PN treatment inclusive day 1
Population: Simultaneous occurring laboratory abnormalities
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Three-Chambered Bag | Newly-occurred Abnormal Laboratory Findings During PN | Metabolic impairment | 1193 Participants |
| Three-Chambered Bag | Newly-occurred Abnormal Laboratory Findings During PN | Any hepatic dysfunction | 1414 Participants |
| Three-Chambered Bag | Newly-occurred Abnormal Laboratory Findings During PN | Any abnormal electrolytes | 1444 Participants |
| Hospital-compounded Bag | Newly-occurred Abnormal Laboratory Findings During PN | Metabolic impairment | 584 Participants |
| Hospital-compounded Bag | Newly-occurred Abnormal Laboratory Findings During PN | Any hepatic dysfunction | 651 Participants |
| Hospital-compounded Bag | Newly-occurred Abnormal Laboratory Findings During PN | Any abnormal electrolytes | 699 Participants |
Secondary
Organ Failure
Percentage of patients presenting at least one organ failure during treatment with PN for each group (3CB vs HCB)
Time frame: Any time during PN treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Three-Chambered Bag | Organ Failure | Single organ failure | 593 Participants |
| Three-Chambered Bag | Organ Failure | Multiple organ failure | 312 Participants |
| Three-Chambered Bag | Organ Failure | Any organ failure | 905 Participants |
| Hospital-compounded Bag | Organ Failure | Any organ failure | 562 Participants |
| Hospital-compounded Bag | Organ Failure | Single organ failure | 255 Participants |
| Hospital-compounded Bag | Organ Failure | Multiple organ failure | 307 Participants |
Secondary
Renal Replacement Therapy
Percentage of patients requiring Renal Replacement Therapy during PN treatment for each group (3CB vs HCB)
Time frame: Patients requiring renal replacement therapy for at least one day during PN treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Three-Chambered Bag | Renal Replacement Therapy | 78 Participants |
| Hospital-compounded Bag | Renal Replacement Therapy | 89 Participants |
Secondary
Sepsis During PN
Percentage of patients presenting at least one episode of Sepsis during treatment with PN for each group (3CB vs HCB)
Time frame: From date of admission to date of discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Three-Chambered Bag | Sepsis During PN | 431 Participants |
| Hospital-compounded Bag | Sepsis During PN | 228 Participants |
Secondary
Treatment With Antimicrobials During PN
Percentage of patients receiving antimicrobial agents during treatment with PN for each group (3CB vs HCB)
Time frame: Any day during PN treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Three-Chambered Bag | Treatment With Antimicrobials During PN | 831 Participants |
| Hospital-compounded Bag | Treatment With Antimicrobials During PN | 370 Participants |
Secondary
Use of Mechanical Ventilation
Percentage of patients requiring mechanical ventilation during PN treatment for each group (3CB vs HCB)
Time frame: Patients requiring mechanical ventilation at any time during PN treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Three-Chambered Bag | Use of Mechanical Ventilation | 410 Participants |
| Hospital-compounded Bag | Use of Mechanical Ventilation | 299 Participants |
Secondary
Use of Vasopressor Treatment
Percentages of patients requiring vasopressor support during PN treatment
Time frame: Patients requiring vasopressor support at any time during treatment with PN
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Three-Chambered Bag | Use of Vasopressor Treatment | 410 Participants |
| Hospital-compounded Bag | Use of Vasopressor Treatment | 291 Participants |