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

Critical Illness Clinical Trial

Official title:

Assessment of the Benefit From Combined Administration of Oral and Intravenous Nutrition - Enriched With Omega-3 Fatty Acids - for Intensive Care Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01162928
• Other study ID #: HC-G-H-0804
• Status: Completed
• Phase: Phase 3
• First received: July 14, 2010
• Last updated: April 26, 2018
• Start date: May 2013
• Est. completion date: November 2017

Study information

• Verified date: April 2018
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT01148589

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion: - signed informed consent

• 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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Drug:
• Nutriflex Omega special + Oxepa
3-chamber-bag combined with enteral nutrition
• Nutriflex Lipid special + Pulmocare
3-chamber-bag combined with enteral nutrition

Locations

Country	Name	City	State
Israel	Rabin Medical Center, Beilinson Campus	Petah-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in blood oxygenation (PaO2/FIO2 ratio)		day 1 to day 6
Secondary	rate of parenteral nutrition associated complications equal or better compared to current practice		day 1 to day 6
Secondary	disease related complications		Day 28
Secondary	28 day-mortality		Day 28
Secondary	changes in fatty acid composition of cell membranes		Day 12