Study of Arginine Free IED in Critically Ill Patients.

NCT01713257 | Completed Phase 4 DMC

• 1 other identifier: CNN-TOP-2010-01
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Critically ill patients

Outcome Measures

Primary Outcomes (1)

• Development of new organ failure

  Development of new organ failure: cardiovascular, respiratory, renal, hematologic, hepatic, neurologic Clinical outcomes: Change of SOFA score or MODS

  10 days

Secondary Outcomes (1)

• Immunologic parameters

  10 days

Study Arms (2)

Immunoenhancing diet

EXPERIMENTAL

Immunoenhancing diet 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: Immunoenhancing diet

Isocaloric, isonitrogenous diet

ACTIVE COMPARATOR

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

Interventions

Immunoenhancing diet DIETARY_SUPPLEMENT

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.

Immunoenhancing diet

Isocaloric, isonitrogenous diet DIETARY_SUPPLEMENT

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.

Isocaloric, isonitrogenous diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ICU patients requiring mechanical ventilation or APACHE II score equal or more than 10
• Patients arrived at ICU within 24 hours before feeding
• Anticipated tube feeding for at least 5 days
• Age of 18 years and older

You may not qualify if:

• Inability to be fed via the gastrointestinal tract
• Allergic to whey protein isolate (WPI), soy protein isolate, glutamine, fish oil or any components in study formulas
• Hemodynamically unstable, requiring significant dose of vasopressor or inotropes infusion (Dopamine or dobutamine \> 5 microgram/kg/min or noradrenaline \> 0.1 microgram/kg/min)
• Known insulin dependent diabetes mellitus
• Cerebral hemorrhage or severe head injury (Glasgow Coma Scale Score ≤ 8)
• Active bleeding requiring ongoing blood transfusion
• Platelet count \< 30,000/mm3 or INR \> 5
• Pre-existing incurable disease (uncontrolled cancer, terminal disease, patient's legal representative not committed to full support)
• On chemotherapy, radiation therapy within the previous 6 months or immunosuppressive regimen (including prednisolone or aspirin at least 7 days consecutively within the previous 4 weeks) or on other investigational drugs
• Any genetic immune or autoimmune disorder; known HIV-positive patients
• Severe chronic liver disease (Child- Pugh score of 11-15)
• Renal failure requiring renal replacement therapy
• Pregnancy or lactation
• Unable to obtain inform consent from patient or his/her legal representative

Sponsors & Collaborators

• Thai Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (3)

Songklanakarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Assoc.Prof.Kaweesak Chittawatanarat

Muang, Chiang Mai, 50200, Thailand

Location

Assoc.Prof.Boonsong Pachanasoonthorn

Muang, Khonkaen, Thailand

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Assist.Prof.Boonsong Pajanasoontorn, MD

  Faculty of Medicine, Khon Kaen University

  PRINCIPAL INVESTIGATOR

• Kaweesak Chittawatanarat, M.D.

  Faculty of Medicine, Chiang Mai University

  PRINCIPAL INVESTIGATOR

• Burapat Sangthong, M.D.

  Department of Surgery, Faculty of Medicine, Songklanagarind University

  PRINCIPAL INVESTIGATOR

• Rungsun Bhurayanontachai, M.D.

  Department of Medicine, Faculty of Medicine, Songklanakarind University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: October 24, 2012
• Study Start: January 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 24, 2012

Record last verified: 2012-10

Locations

TH (3)