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

Phase 3

Completed

• Conditions: Critical Illness
• Interventions: Drug: Nutriflex Lipid special + Pulmocare; Drug: Nutriflex Omega special + Oxepa

• Registration Number: NCT01162928
• Lead Sponsor: B. Braun Melsungen AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-14
• Study First Submitted QC: 2010-07-14
• Study First Posted: 2010-07-15
• Study Start: 2013-05
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-26
• Last Update Posted: 2018-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Nutriflex Lipid special + Pulmocare	3-chamber-bag combined with Pulmocare
1	Nutriflex Omega special + Oxepa	3-chamber-bag combined with Oxepa

Primary Outcome Measures

Name	Time	Method
change in blood oxygenation (PaO2/FIO2 ratio)	day 1 to day 6

Secondary Outcome Measures

Name	Time	Method
disease related complications	Day 28
rate of parenteral nutrition associated complications equal or better compared to current practice	day 1 to day 6
28 day-mortality	Day 28
changes in fatty acid composition of cell membranes	Day 12

Trial Locations

Locations (1)

Rabin Medical Center, Beilinson Campus; 🇮🇱 Petah-Tikva, Israel