Different Lipid Emulsions in Acute Lung Injury Patients | NCT01814956

Studies
Different Lipid Emulsions in Acute Lung Injury Patients

NCT01814956

Sponsor

B. Braun Melsungen AG

Status

Terminated

Last Update Posted

Jul 20, 2016Estimated

Enrollment

1Actual

Phase

Phase 4

Conditions

Parenteral Nutrition

Interventions

Lipoplus 20%
Lipofundin N 20%

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-003397-82	EudraCT Number

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low recruitment

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Mar 18, 2013

First Submission Date that Met QC Criteria

Mar 18, 2013

First Posted Date

Mar 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2016

Last Update Posted Date

Jul 20, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Lipoplus 20%	Drug	Lipoplus 20% (MCT/LCT/FO) i.v. lipid emulsion for parenteral nutrition	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in blood oxygenation (PaO2/FiO2ratio)		change day 1 to day 6

Secondary Outcomes

Measure	Description	Time Frame
Triglycerides		day 1 to day 16
Sequential Organ Failure Assessment		day 1 to day 28

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion:

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

Exclusion:

Exclusion of pregnancy in women with child-bearing potential
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 :

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University Clinic Giessen		Giessen		35392	Germany

Condition Browse Module

MeSH Terms

ID	Term
D006963	Hyperphagia

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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