Enteral Glutamine in Critical Illness

NCT00318331 | Terminated Phase 2 DMC

• 1 other identifier: Glutamine
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Glutamine is an amino acid which is rapidly depleted in critical illness. It is used as energy by cells that line the gut, vital for immune system function, and works as an anti-oxidant. Glutamine supplementation has been shown to improve outcomes in ICU patients. We hypothesize that critically ill patients given extra glutamine will have less of an inflammatory response and therefore better outcomes than patients not given extra glutamine. Our study randomizes patients to tube feeding with OR without extra glutamine to see if it affects patient outcomes as well as markers of inflammation.

Conditions

Critical Illness; Sepsis; Respiratory Insufficiency

Keywords

Glutamine; Critical Illness; Enteral Feeding; Blood Volume Analysis

Outcome Measures

Primary Outcomes (4)

• Mortality

  28 days

• Length of ICU stay

  28 days

• Number of Ventilator Days

  28 days

• Number of days receiving antibiotics

  28 days

Secondary Outcomes (6)

• Change in APACHE Score

  72 hours

• Change in Number of SIRS Criteria

  72 hours

• Change in Capillary Leak as measured by blood volume analysis

  72 hours

• Change in CRP

  72 hours

• Correlation between capillary permeability and APACHE Score

  72 hours

Study Arms (2)

A

ACTIVE COMPARATOR

Will receive enteral glutamine

Drug: Glutamine

B

NO INTERVENTION

No enteral glutamine given

Interventions

Glutamine DRUG

Group A patients will receive 0.5g/kg/day of enteral glutamine daily while they are receiving tube feeds or at the end of 28 days (whichever comes first)

A

Eligibility Criteria

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

You may qualify if:

• Admission to MICU/ CICU
• Age greater than or equal to 18 years old
• Requirement for enteral nutrition
• Presence or planned insertion of central venous catheter as part of routine medical care
• Requirement for mechanical ventilation
• APACHE II Score \>/= 15

You may not qualify if:

• Female of child-bearing age (i.e. less than 45 years old)
• Enteral nutrition begun prior to randomization
• Receiving Total Parenteral Nutrition
• Requirement for protein restriction
• Creatinine \>4 mg/dl
• History of cirrhosis and/or clinical signs of heptic encephalopathy

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Hospital

Newark, Delaware, 19713, United States

Location

Related Publications (57)

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MeSH Terms

Conditions

Critical Illness; Sepsis; Respiratory Insufficiency

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Officials

• Michael DePietro, M.D.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 24, 2006
• First Posted: April 26, 2006
• Study Start: May 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: March 13, 2008

Record last verified: 2008-03

Locations

US (1)