NCT01814956

TerminatedPhase 4

Different Lipid Emulsions in Acute Lung Injury Patients

B. Braun Melsungen AG Source

B. Braun Melsungen AG

ClinicalTrials.gov

Compare

Other study identifiers

Sponsor study identifier

HC-G-H-0813

Secondary identifiers

2011-003397-82

EUDRACT_NUMBER

Study Type

interventional

Actual enrollment (reported)

1

Locations

1 country

Sites

1

Timeline

Study Start

March 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

May 2015

Actual (reported)

Study Completion

May 2015

Actual (reported)

Brief Summary

Aim is to investigate the influence of an early supply of parenteral nutrition including a fish oil containing lipid emulsion on the course of acute lung injury in the intensive care unit. In comparison, a standard parenteral nutrition with a soybean oil based emulsion will be used. Data obtained in this trial may provide evidence for a beneficial effect of fish oil derived omega-3 fatty acids in parenteral nutrition regarding their influence on acute lung injury.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 1 participants
Study completion date: May 2015
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2013
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
March 18, 2013
Actual (reported)
First Posted
March 20, 2013
Actual (reported)
Primary Completion
May 2015
Actual (reported)
Study Completion
May 2015
Actual (reported)

Last Updated: July 20, 2016
Status Verified: July 2016
Last Update Submitted: July 19, 2016

Conditions

Parenteral Nutrition

Outcome Measures

Primary Outcomes (1)

change in blood oxygenation (PaO2/FiO2ratio)
change day 1 to day 6

Secondary Outcomes (2)

Triglycerides
day 1 to day 16
Sequential Organ Failure Assessment
day 1 to day 28

Study Arms (2)

1

EXPERIMENTAL

i.v. lipid emulsion for parenteral nutrition

Drug: Lipoplus 20%

2

ACTIVE COMPARATOR

i.v. lipid emulsion for parenteral nutrition

Drug: Lipofundin N 20%

Interventions

Lipoplus 20%Drug

Lipoplus 20% (MCT/LCT/FO) i.v. lipid emulsion for parenteral nutrition

1

Lipofundin N 20%Drug

Lipofundin N 20% (LCT, soy bean oil) i.v. lipid emulsion for parenteral nutrition

2

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Acute Lung Injury as a result of proven pneumonia (x-ray) or witnessed aspiration
Oxygenation factor ≤ 300

Sponsors & Collaborators

B. Braun Melsungen AG
Industrylead

Study Sites (1)

University Clinic Giessen

Giessen, 35392, Germany

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Enrollment

1 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 20, 2013

Study Start

March 2013

Date type not reported

This date has not been verified as actual or estimated.

NCT06625931

Clinical Trial to Evaluate the Safety and Efficacy of NTCB01-1 in Patients Who Require Parenteral Nutrition

Phase 3Completed

NCT06625957

Clinical Trial to Evaluate the Safety and Efficacy of NTCB02-1 in Patients Who Require Parenteral Nutrition

Phase 3Recruiting

NCT00672854

Study Comparing a Soybean Oil-Based With an Olive Oil-Based Lipid Emulsion in ICU Patients Requiring TPN

Phase 2/3Completed

NCT05788588

A Phase Ⅲ Study of HR19006 Injection in Postsurgical Parenteral Nutrition

Phase 3Unknown

NCT00451646

Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition

Phase 3Completed

NCT04816734

Initial Parenteral Nutrition Education of Parent Assessment Plan

Not ApplicableCompleted

\<= 72 hours since intubation or non-invasive ventilatory support by mask at screening

Expected need for parenteral nutrition for at least 5 days

Male or female ≥ 18 years of age

You may not qualify if:

Cardiogenic pulmonary oedema
Previous (\< 1 month) or ongoing need for corticosteroids \>0.1 mg/kg/d prednisolon-equivalent or other immune suppressive treatment
Active or previous (\< 1 year) treatment for solid or haematologic malignancy
Serum triglycerides \> 300 mg/dl at screening
Alterations of coagulation (thrombocytes \<100 Giga/l), aPTT \> 60 sec, INR ≥ 2.5 without therapeutic intervention
Autoimmune disease or HIV (according to medical history)
Known or suspected drug abuse
General contraindications to infusion therapy :

Contact the study team to confirm eligibility.

Primary Completion

May 2015

Actual (reported)

Study Completion

May 2015

Actual (reported)

Last Updated

July 20, 2016

Record last verified: 2016-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01814956
Data provider: ClinicalTrials.gov
Source updated: 2016-07-20
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:26 UTC

Locations

DE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations