Trial · NCT03284398
Three-Chamber Bags Retrospective Study in Spain
NCT03284398, Completed, Fresenius Kabi; results first posted 2021-01-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Three-Chamber Bags Retrospective Study in Spain. Trials, record NCT03284398. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03284398
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Three-Chamber Bags Retrospective Study in Spain
- NCT number
- NCT03284398
- Status
- Completed
- Enrollment
- 3,723 participants, actual
- Lead sponsor
- Fresenius Kabi
- Conditions
- Parenteral Nutrition, Blood Stream Infection
- First posted
- 2017-09-15
- Last updated
- 2021-01-29
- Results first posted
- 2021-01-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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) |
| Secondary | 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) |
| Secondary | Use of Vasopressor Treatment | Patients requiring vasopressor support at any time during treatment with PN | Percentages of patients requiring vasopressor support during PN treatment |
| Secondary | 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) |
| Secondary | 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) |
| Secondary | 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) |
| Secondary | 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) |
| Secondary | 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) |
| Secondary | 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) |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Sepsis During PN | From date of admission to date of discharge | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Treatment With Antimicrobials During PN | Any day during PN treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Use of Vasopressor Treatment | Patients requiring vasopressor support at any time during treatment with PN | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Use of Mechanical Ventilation | Patients requiring mechanical ventilation at any time during PN treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Renal Replacement Therapy | Patients requiring renal replacement therapy for at least one day during PN treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Newly-occurred Abnormal Laboratory Findings During PN | During PN treatment inclusive day 1 | Simultaneous occurring laboratory abnormalities | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Organ Failure | Any time during PN treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Hospital Length of Stay (LOS) | Duration in days from admission to death or discharge for each treatment arm | Days | NUMBER | |
| SECONDARY | Length of Stay in the ICU | All patients admitted in the ICU at any time during PN treatment | Days | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB) | Three-Chambered Bag | 127 | Participants | ||
| Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB) | Hospital-compounded Bag | 106 | Participants | ||
| Sepsis During PN | Three-Chambered Bag (3CB) | 431 | Participants | ||
| Sepsis During PN | Hospital-Compounded Bag (HCB) | 228 | Participants | ||
| Treatment With Antimicrobials During PN | Three-chambered Bag (3CB) | 831 | Participants | ||
| Treatment With Antimicrobials During PN | Hospital-Compounded Bag (HCB) | 370 | Participants | ||
| Use of Vasopressor Treatment | Three-Chambered Bag (3CB) | 410 | Participants | ||
| Use of Vasopressor Treatment | Hospital-compounded Bag (HCB) | 291 | Participants | ||
| Use of Mechanical Ventilation | Three-Chambered Bag (3CB) | 410 | Participants | ||
| Use of Mechanical Ventilation | Hospital-compounded Bag (HCB) | 299 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Three-chambered Bag (3CB) | 2,753 | |
| Overall Study | STARTED | Hospital-Compounded Bag (HCB) | 970 | |
| Overall Study | COMPLETED | Three-chambered Bag (3CB) | 2,753 | |
| Overall Study | COMPLETED | Hospital-Compounded Bag (HCB) | 970 | |
| Overall Study | NOT COMPLETED | Three-chambered Bag (3CB) | 0 | |
| Overall Study | NOT COMPLETED | Hospital-Compounded Bag (HCB) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Three-Chambered Bag (3CB) | 0 | 0 |
| Total, all-cause mortality | Hospital-compounded Bag (HCB) | 0 | 0 |
| Total, other adverse events | Three-Chambered Bag (3CB) | 0 | 0 |
| Total, other adverse events | Hospital-compounded Bag (HCB) | 0 | 0 |
| Total, serious adverse events | Three-Chambered Bag (3CB) | 0 | 0 |
| Total, serious adverse events | Hospital-compounded Bag (HCB) | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Three-chambered Bag (3CB) vs Hospital-Compounded Bag (HCB): Treatment With Antimicrobials During PN | Trial comparisons |
| Three-Chambered Bag (3CB) vs Hospital-compounded Bag (HCB): Renal Replacement Therapy | Trial comparisons |
| Three-Chambered Bag (3CB) vs Hospital-compounded Bag (HCB): Use of Mechanical Ventilation | Trial comparisons |
| Three-Chambered Bag (3CB) vs Hospital-Compounded Bag (HCB): Sepsis During PN | Trial comparisons |
| Three-Chambered Bag vs Hospital-compounded Bag: Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB) | Trial comparisons |
| Three-Chambered Bag (3CB) vs Hospital-compounded Bag (HCB): Use of Vasopressor Treatment | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03284398
GET https://conductscience.org/api/trials/v1/NCT03284398/results?page=2