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

Primary Purpose

Critical Illness

Status

Completed

Phase

Phase 3

Locations

Israel

Study Type

Interventional

Intervention

Nutriflex Omega special + Oxepa

Nutriflex Lipid special + Pulmocare

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring critically ill, mechanically ventilated patients requiring enteral and parenteral nutritional support

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rabin Medical Center, Beilinson Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

3-chamber-bag combined with Oxepa

3-chamber-bag combined with Pulmocare

Outcomes

Primary Outcome Measures

change in blood oxygenation (PaO2/FIO2 ratio)

Secondary Outcome Measures

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

disease related complications

28 day-mortality

changes in fatty acid composition of cell membranes

Full Information

NCT ID

NCT01162928

First Posted

July 14, 2010

Last Updated

April 26, 2018

Sponsor

B. Braun Melsungen AG

1. Study Identification

Unique Protocol Identification Number

NCT01162928

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

May 2013 (undefined)

Primary Completion Date

November 2017 (Actual)

Study Completion Date

November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

B. Braun Melsungen AG

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Illness

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

3-chamber-bag combined with Oxepa

Arm Title

Arm Type

Active Comparator

Arm Description

3-chamber-bag combined with Pulmocare

Intervention Type

Drug

Intervention Name(s)

Nutriflex Omega special + Oxepa

Intervention Description

3-chamber-bag combined with enteral nutrition

Intervention Type

Drug

Intervention Name(s)

Nutriflex Lipid special + Pulmocare

Intervention Description

3-chamber-bag combined with enteral nutrition

Primary Outcome Measure Information:

Title

change in blood oxygenation (PaO2/FIO2 ratio)

Time Frame

day 1 to day 6

Secondary Outcome Measure Information:

Title

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

Time Frame

day 1 to day 6

Title

disease related complications

Time Frame

Day 28

Title

28 day-mortality

Time Frame

Day 28

Title

changes in fatty acid composition of cell membranes

Time Frame

Day 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierre Singer, MD

Organizational Affiliation

Rabin Medical Center, Beilinson Campus

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rabin Medical Center, Beilinson Campus

City

Petah-Tikva

ZIP/Postal Code

49100

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

33932802

Citation

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.

Results Reference

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

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