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Fish OIL Optimal dosE Determination Study

NCT01146821 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2017-04-19

No results posted yet for this study

Summary

The primary objective of this trial is to determine the safety and efficacy of IV fish oil doses of 0.20 g/kg and 0.50 g/kg, compared to a control group, in critically ill patients with severe sepsis by examining organ function, blood safety and biochemical parameters, markers of systemic inflammation and innate immunological parameters

Conditions

Interventions

DIETARY_SUPPLEMENT

0.20 gm/kg fish oil

Group 2: 7 patients will receive 0.20gm/kg of ideal body weight \[IBW\] fish oil in addition to standard care

DIETARY_SUPPLEMENT

0.50 gm/kg fish oil

Group 3: 7 patients will receive 0.50 gm/kg of ideal body weight \[IBW\] fish oil in addition to standard care.

Sponsors & Collaborators

  • University of Giessen

    collaborator OTHER

  • Clinical Evaluation Research Unit at Kingston General Hospital

    collaborator OTHER

  • GWT-TUD GmbH

    collaborator OTHER

  • University Hospital Carl Gustav Carus

    lead OTHER

Principal Investigators

  • Axel R. Heller, MD · University Hospital Dresden, Germany

  • Daren Heyland, MD, PhD · Kingston General Hospital, Canada

  • Rupinder Dhaliwal, RD · Kingston General Hospital, Canada

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01146821 on ClinicalTrials.gov