Parenteral Nutrition With Intravenous and Oral Fish Oil for Intensive Care Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2017-11-30

Brief Summary

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The primary objective is to assess the effect of fish oil-enriched enteral and parenteral nutrition on blood oxygenation in critically ill patients.

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Detailed Description

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Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

3-chamber-bag combined with Oxepa

Group Type EXPERIMENTAL

Nutriflex Omega special + Oxepa

Intervention Type DRUG

3-chamber-bag combined with enteral nutrition

2

3-chamber-bag combined with Pulmocare

Group Type ACTIVE_COMPARATOR

Nutriflex Lipid special + Pulmocare

Intervention Type DRUG

3-chamber-bag combined with enteral nutrition

Interventions

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Nutriflex Omega special + Oxepa

3-chamber-bag combined with enteral nutrition

Intervention Type DRUG

Nutriflex Lipid special + Pulmocare

3-chamber-bag combined with enteral nutrition

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* mechanically-ventilated adults (age 18-80) admitted to Intensive Care Unit,
* enteral nutrition does not meet the nutrition goal (at least 80 % of the resting energy expenditure) within the past 36 hours
* APACHE II score above the median value of the intensive care unit (id est \> 20)

Exclusion: - do not resuscitate status

* cardiogenic pulmonary edema
* previous (\< 1 month) or ongoing need for corticosteroids \> 0.1 mg/kg prednisolon- equi-valent or other immune suppressive treatment
* serum triglycerides \> 300 mg/dl at screening
* alterations of coagulation (platelets \<100.000 mm3), PTT \> 60 sec, INR ≥ 2.5 without therapeutic intervention
* pregnancy
* participation in a clinical study with an investigational drug within one month prior to the start of this clinical trial
* known or suspected drug abuse
* general contraindications for infusion therapy such as acute pulmonary oedema, hyper-hydration and decompensated cardiac insufficiency
* known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients
* autoimmune disease or HIV
* uncompensated hemodynamical failure of any origin (hemorrhagic shock, myocardial infarction, cardiac failure)
* uncompensated ketoacidosis caused by Diabetes mellitus within 7 days prior to onset of study
* uncompensated renal insufficiency with serum creatinine \> 1.5 mg/dL (\> 133 µmol/L)
* patients with severe liver dysfunction with bilirubin \> 2.5 mg/dL (\> 43 µmol/L)
* necrotizing pancreatitis

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No