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Study of Arginine Free IED in Critically Ill Patients.

NCT01713257 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2012-10-24

No results posted yet for this study

Summary

This study intends to investigate the clinical outcomes of a new immunoenhancing formula which composed arginine free compare to isonitrogenous, isocaloric standard formula in ICU patients.The study design is multicenter, double-blind randomized controlled study with 3 periods of Screening, Run-in and Randomization period.

Primary Objective: To evaluate the clinical outcomes of immunoenhancing diet (IED) arginine free in medical-surgical ICU patients.

Secondary Objective: To evaluate the immunologic effects and safety of IED arginine free formula.

Conditions

  • Critical Illness

Interventions

DIETARY_SUPPLEMENT

Immunoenhancing diet

Enteral feeding until Day 10 or the day of discharge if earlier than Day 10. The goal of caloric intake is 25 kcal/kg/day and protein 1.2 g/kg/day.

DIETARY_SUPPLEMENT

Isocaloric, isonitrogenous diet

Enteral feeding until Day 10 or the day of discharge if earlier than Day 10. The goal of caloric intake is 25 kcal/kg/day and protein 1.2 g/kg/day.

Sponsors & Collaborators

  • Thai Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Assist.Prof.Boonsong Pajanasoontorn, MD · Faculty of Medicine, Khon Kaen University

  • Kaweesak Chittawatanarat, M.D. · Faculty of Medicine, Chiang Mai University

  • Burapat Sangthong, M.D. · Department of Surgery, Faculty of Medicine, Songklanagarind University

  • Rungsun Bhurayanontachai, M.D. · Department of Medicine, Faculty of Medicine, Songklanakarind University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Thailand

Study Locations

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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 NCT01713257 on ClinicalTrials.gov