Parenteral NutritionNCT03284398
Three-Chamber Bags Retrospective Study in Spain
An observational study of Parenteral Nutrition and Blood Stream Infection, run by Fresenius Kabi at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parenteral Nutrition, Blood Stream Infection
- How many people
- 3,723 participants
- Where
- 2 sitesSpain
- Study dates
- 14 Dec 2017to 31 May 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital de Manacor
Manacor, Balearic Islands, 7500
About this study
Official title: Observational Retrospective Analysis Assessing the Influence of Three-Chamber Bags Compared to Hospital Compounded Parenteral Nutrition Bags on Blood Stream Infections
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.
Read the 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
- Keywords
- parenteral nutrition, ICU, 3-chamber bags, ICD-9-CM, BSI, Medical records system, computerized
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parenteral nutrition bag type | Groups with different parenteral nutrition bags (3CBs or HCBs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Entire study period, from January 1, 2013 and December 31, 2015
Secondary outcomes (9)
Sepsis During PN
Percentage of patients presenting at least one episode of Sepsis during treatment with PN for each group (3CB vs HCB)
Measured: From date of admission to date of discharge
Treatment With Antimicrobials During PN
Percentage of patients receiving antimicrobial agents during treatment with PN for each group (3CB vs HCB)
Measured: Any day during PN treatment
Use of Vasopressor Treatment
Percentages of patients requiring vasopressor support during PN treatment
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Any time during PN treatment
Hospital Length of Stay (LOS)
Hospital length of stay in days for patients for each group (3CB vs HCB)
Measured: 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)
Measured: All patients admitted in the ICU at any time during PN treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start14 Dec 2017
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parenteral NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 3,723 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John F Stover, Study chair, Fresenius Kabi Deutschland GmbH, Borkenberg 14, 61440 Oberursel, GermanyJuan Carlos M González, Principal investigator, Hospital Universitario 12 de Octubre, 28041 Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284398
- Sponsor's protocol ID
- 3CBs-001-CNI
- Status last verified
- Jan 2021
- First submitted
- 4 Sep 2017
- Last updated
- 29 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Retrospective Analysis Assessing the Influence of Three-Chamber Bags Compared to Hospital Compounded Parenteral Nutrition Bags on Blood Stream Infections
- ClinicalTrials.gov ID
- NCT03284398
- Acronym / sponsor ID
- 3CBs-001-CNI
- Conditions
- Parenteral Nutrition, Blood Stream Infection
- Keywords
- parenteral nutrition, ICU, 3-chamber bags, ICD-9-CM, BSI, Medical records system, computerized
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,723 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 15 Sep 2017 (actual)
- Results
- Posted 8 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parenteral nutrition bag type | – | –Groups with different parenteral nutrition bags (3CBs or HCBs) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB)
Time frame: 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
9 secondary outcomes
Sepsis During PN
Time frame: From date of admission to date of discharge
Treatment With Antimicrobials During PN
Time frame: Any day during PN treatment
Use of Vasopressor Treatment
Time frame: Patients requiring vasopressor support at any time during treatment with PN
Use of Mechanical Ventilation
Time frame: Patients requiring mechanical ventilation at any time during PN treatment
Renal Replacement Therapy
Time frame: Patients requiring renal replacement therapy for at least one day during PN treatment
Newly-occurred Abnormal Laboratory Findings During PN
Time frame: During PN treatment inclusive day 1
Organ Failure
Time frame: Any time during PN treatment
Hospital Length of Stay (LOS)
Time frame: Duration in days from admission to death or discharge for each treatment arm
Length of Stay in the ICU
Time frame: All patients admitted in the ICU at any time during PN treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John F Stover study chair
Fresenius Kabi Deutschland GmbH, Borkenberg 14, 61440 Oberursel, Germany
Juan Carlos M González principal investigator
Hospital Universitario 12 de Octubre, 28041 Madrid, Spain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parenteral Nutrition and Blood Stream Infection, run by Fresenius Kabi at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB) (time frame: Entire study period, from January 1, 2013 and December 31, 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.