NCT03284398 is a clinical trial in Parenteral Nutrition, sponsored by Fresenius Kabi.

Who is sponsoring NCT03284398?

NCT03284398 is sponsored by Fresenius Kabi.

What condition does NCT03284398 study?

NCT03284398 studies Parenteral Nutrition, Blood Stream Infection.

Is NCT03284398 still recruiting?

NCT03284398 is currently completed. Last updated 29 January 2021.

Are results published for NCT03284398?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-01-29 · How we verify

NCT03284398

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Three-Chamber Bags Retrospective Study in Spain

Completed Results posted Last updated 29 January 2021

What this trial tests

trial in Parenteral Nutrition in 3,723 participants. Completed in 31 May 2019.

Timeline

14 December 2017

Primary endpoint
31 May 2019

31 May 2019

Quick facts

Lead sponsor	Fresenius Kabi
Status	Completed
Study type	OBSERVATIONAL
Enrollment	3,723
Start date	14 December 2017
Primary completion	31 May 2019
Estimated completion	31 May 2019
Sites	2 locations across Spain

Conditions studied

Parenteral Nutrition — all drugs for Parenteral Nutrition →
Blood Stream Infection — all drugs for Blood Stream Infection →

Sponsor

Fresenius Kabi — full company profile →

Who can join

18 and older, any sex, with Parenteral Nutrition or Blood Stream Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Patients Presenting With a Confirmed Microbial Blood Stream Infection During Treatment With PN for Each Group (3CB vs HCB) Primary · 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

Group	Value	95% CI
Three-Chambered Bag	127
Hospital-compounded Bag	106

Sepsis During PN Secondary · 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)

Group	Value	95% CI
Three-Chambered Bag (3CB)	431
Hospital-Compounded Bag (HCB)	228

Treatment With Antimicrobials During PN Secondary · Any day during PN treatment

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

Group	Value	95% CI
Three-chambered Bag (3CB)	831
Hospital-Compounded Bag (HCB)	370

Use of Vasopressor Treatment Secondary · Patients requiring vasopressor support at any time during treatment with PN

Percentages of patients requiring vasopressor support during PN treatment

Group	Value	95% CI
Three-Chambered Bag (3CB)	410
Hospital-compounded Bag (HCB)	291

Use of Mechanical Ventilation Secondary · 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)

Group	Value	95% CI
Three-Chambered Bag (3CB)	410
Hospital-compounded Bag (HCB)	299

Renal Replacement Therapy Secondary · 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)

Group	Value	95% CI
Three-Chambered Bag (3CB)	78
Hospital-compounded Bag (HCB)	89

Newly-occurred Abnormal Laboratory Findings During PN Secondary · During PN treatment inclusive day 1

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

Metabolic impairment

Group	Value	95% CI
Three-Chambered Bag (3CB)	1193
Hospital-compounded Bag (HCB)	584

Any hepatic dysfunction

Group	Value	95% CI
Three-Chambered Bag (3CB)	1414
Hospital-compounded Bag (HCB)	651

Any abnormal electrolytes

Group	Value	95% CI
Three-Chambered Bag (3CB)	1444
Hospital-compounded Bag (HCB)	699

Organ Failure Secondary · Any time during PN treatment

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

Any organ failure

Group	Value	95% CI
Three-Chambered Bag (3CB)	905
Hospital-compounded Bag (HCB)	562

Single organ failure

Group	Value	95% CI
Three-Chambered Bag (3CB)	593
Hospital-compounded Bag (HCB)	255

Multiple organ failure

Group	Value	95% CI
Three-Chambered Bag (3CB)	312
Hospital-compounded Bag (HCB)	307

Hospital Length of Stay (LOS) Secondary · 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)

Group	Value	95% CI
Three-Chambered Bag (3CB)	26,601
Hospital-compounded Bag (HCB)	30,384

Length of Stay in the ICU Secondary · 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)

Group	Value	95% CI
Three-Chambered Bag (3CB)	3,017
Hospital-compounded Bag (HCB)	3,772

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Parenteral Nutrition

Currently open trials in the same condition.

NCT06625957 — Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 in Patients Who Require Parenteral Nutrition · Phase 3 · recruiting
NCT06510348 — Achieving nuTritional Target in criticAlly Ill patieNts With iMpairEd gastroiNtesTinal Dysfunction · NA · recruiting
NCT06525753 — Weaning is Winning? (WeWin Study) · recruiting

Other Fresenius Kabi trials

Trials by the same sponsor.

NCT06274788 — Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Ome · recruiting
NCT05190484 — bIosimilar of aDalimumab, an European evAluation · unknown
NCT04807478 — Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC) · withdrawn
NCT05257031 — Efficacy and Safety of SmofKabiven Extra Nitrogen for Parenteral Nutrition in Patients Receiving Intensive Care · Phase 3 · completed
NCT05051943 — A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Respon · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03284398 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fresenius Kabi
Last refreshed: 29 January 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03284398.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing