NCT01162928

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2013

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
2.8 years until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

April 27, 2018

Status Verified

April 1, 2018

Enrollment Period

4.5 years

First QC Date

July 14, 2010

Last Update Submit

April 26, 2018

Conditions

Critical Illness

Keywords

critically ill, mechanically ventilated patients requiring enteral and parenteral nutritional support

Outcome Measures

Primary Outcomes (1)

  • change in blood oxygenation (PaO2/FIO2 ratio)

    day 1 to day 6

Secondary Outcomes (4)

  • rate of parenteral nutrition associated complications equal or better compared to current practice

    day 1 to day 6

  • disease related complications

    Day 28

  • 28 day-mortality

    Day 28

  • changes in fatty acid composition of cell membranes

    Day 12

Study Arms (2)

1

EXPERIMENTAL

3-chamber-bag combined with Oxepa

Drug: Nutriflex Omega special + Oxepa

2

ACTIVE COMPARATOR

3-chamber-bag combined with Pulmocare

Drug: Nutriflex Lipid special + Pulmocare

Interventions

Nutriflex Omega special + OxepaDRUG

3-chamber-bag combined with enteral nutrition

1
Nutriflex Lipid special + PulmocareDRUG

3-chamber-bag combined with enteral nutrition

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center, Beilinson Campus

Petah Tikva, 49100, Israel

Location

Related Publications (1)

  • Singer P, Bendavid I, Mesilati-Stahy R, Green P, Rigler M, Lev S, Schif-Zuck S, Amiram A, Theilla M, Kagan I. Enteral and supplemental parenteral nutrition enriched with omega-3 polyunsaturated fatty acids in intensive care patients - A randomized, controlled, double-blind clinical trial. Clin Nutr. 2021 May;40(5):2544-2554. doi: 10.1016/j.clnu.2021.03.034. Epub 2021 Apr 1.

    PMID: 33932802DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pierre Singer, MD

    Rabin Medical Center, Beilinson Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
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

July 14, 2010

First Posted

July 15, 2010

Study Start

May 1, 2013

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

April 27, 2018

Record last verified: 2018-04

Locations

IL(1)