Trial Outcomes & Findings for Three-Chamber Bags Retrospective Study in Spain (NCT NCT03284398)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

3723 participants

Primary outcome timeframe

Entire study period, from January 1, 2013 and December 31, 2015

Results posted on

2021-01-29

Participant Flow

Retrospective cohort study. Data collection from medical records

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	2753	970
Overall Study COMPLETED	2753	970
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Three-Chambered Bag (3CB) n=2753 Participants 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).	Hospital-compounded Bag (HCB) n=970 Participants 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).	Total n=3723 Participants Total of all reporting groups
Age, Continuous	66.8 years STANDARD_DEVIATION 15.2 • n=2753 Participants	66.5 years STANDARD_DEVIATION 14.8 • n=970 Participants	66.8 years STANDARD_DEVIATION 15.2 • n=3723 Participants
Sex: Female, Male Female	1144 Participants n=2753 Participants	354 Participants n=970 Participants	1498 Participants n=3723 Participants
Sex: Female, Male Male	1609 Participants n=2753 Participants	616 Participants n=970 Participants	2225 Participants n=3723 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Spain	2753 participants n=2753 Participants	970 participants n=970 Participants	3723 participants n=3723 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Three-Chambered Bag n=2753 Participants Treatment with industrially-compounded PN formulation in three-chambered bag	Hospital-compounded Bag n=970 Participants Treatment with Hospital-compounded PN bag
Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB)	127 Participants	106 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Three-Chambered Bag n=2753 Participants Treatment with industrially-compounded PN formulation in three-chambered bag	Hospital-compounded Bag n=970 Participants Treatment with Hospital-compounded PN bag
Sepsis During PN	431 Participants	228 Participants

SECONDARY outcome

Timeframe: Any day during PN treatment

Percentage of patients receiving antimicrobial agents during treatment with PN for each group (3CB vs HCB)

Outcome measures

Outcome measures
Measure	Three-Chambered Bag n=2753 Participants Treatment with industrially-compounded PN formulation in three-chambered bag	Hospital-compounded Bag n=970 Participants Treatment with Hospital-compounded PN bag
Treatment With Antimicrobials During PN	831 Participants	370 Participants

SECONDARY outcome

Timeframe: Patients requiring vasopressor support at any time during treatment with PN

Percentages of patients requiring vasopressor support during PN treatment

Outcome measures

Outcome measures
Measure	Three-Chambered Bag n=2753 Participants Treatment with industrially-compounded PN formulation in three-chambered bag	Hospital-compounded Bag n=970 Participants Treatment with Hospital-compounded PN bag
Use of Vasopressor Treatment	410 Participants	291 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Three-Chambered Bag n=2753 Participants Treatment with industrially-compounded PN formulation in three-chambered bag	Hospital-compounded Bag n=970 Participants Treatment with Hospital-compounded PN bag
Use of Mechanical Ventilation	410 Participants	299 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Three-Chambered Bag n=2753 Participants Treatment with industrially-compounded PN formulation in three-chambered bag	Hospital-compounded Bag n=970 Participants Treatment with Hospital-compounded PN bag
Renal Replacement Therapy	78 Participants	89 Participants

SECONDARY outcome

Timeframe: During PN treatment inclusive day 1

Population: Simultaneous occurring laboratory abnormalities

Percentage of patients presenting newly-occurred abnormal laboratory results during PN for each group (3CB vs HCB)

Outcome measures

Outcome measures
Measure	Three-Chambered Bag n=2753 Participants Treatment with industrially-compounded PN formulation in three-chambered bag	Hospital-compounded Bag n=970 Participants Treatment with Hospital-compounded PN bag
Newly-occurred Abnormal Laboratory Findings During PN Metabolic impairment	1193 Participants	584 Participants
Newly-occurred Abnormal Laboratory Findings During PN Any hepatic dysfunction	1414 Participants	651 Participants
Newly-occurred Abnormal Laboratory Findings During PN Any abnormal electrolytes	1444 Participants	699 Participants

SECONDARY outcome

Timeframe: Any time during PN treatment

Percentage of patients presenting at least one organ failure during treatment with PN for each group (3CB vs HCB)

Outcome measures

Outcome measures
Measure	Three-Chambered Bag n=2753 Participants Treatment with industrially-compounded PN formulation in three-chambered bag	Hospital-compounded Bag n=970 Participants Treatment with Hospital-compounded PN bag
Organ Failure Any organ failure	905 Participants	562 Participants
Organ Failure Single organ failure	593 Participants	255 Participants
Organ Failure Multiple organ failure	312 Participants	307 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Three-Chambered Bag n=2753 Participants Treatment with industrially-compounded PN formulation in three-chambered bag	Hospital-compounded Bag n=970 Participants Treatment with Hospital-compounded PN bag
Hospital Length of Stay (LOS)	26,601 Days	30,384 Days

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Three-Chambered Bag n=2753 Participants Treatment with industrially-compounded PN formulation in three-chambered bag	Hospital-compounded Bag n=970 Participants Treatment with Hospital-compounded PN bag
Length of Stay in the ICU	3,017 Days	3,772 Days

Adverse Events

Three-Chambered Bag (3CB)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hospital-compounded Bag (HCB)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. med. Martin Westphal

Fresenius Kabi Deutschland, GmbH

Phone: +49 6172 686-7348

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place