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Clinical Trials: Phase III Study on the Efficacy of Glutamine Dipeptide-Supplemented Parenteral Nutrition in Surgical ICU Patients

 


Phase III Study on the Efficacy of Glutamine Dipeptide-Supplemented Parenteral Nutrition in Surgical ICU Patients


Trial Focus

Trial Focus

Drugs (Pharmacology), Infections, Intensive Care/Critical Care

Objective

        
This study is designed to determine the effect of administering parenteral glutamine dipeptide on rates of nosocomial infections and hospital mortality in patients requiring SICU care AND parenteral nutrition after cardiac, vascular or intestinal surgery. Consented patients are randomized to receive standard TPN or glutamine dipeptide-supplemented TPN.

IRB Protocol #

05-0882

Trial Status

In Progress

Contact

Elizabeth Luzier RN at 303-266-1686

Eligibility and Other Participant Information


Inclusion Criteria
•18-90 years old
•BMI < 40kg/m2
•currently requiring SICU care
•up to 14 days after an open surgical procedure: CABG, valve, non-neurosurg. vascular, intestinal resection
•expected to require TPN for 7+ days after entry
•central venous access for TPN is present

Exclusion Criteria
•not currently receiving cancer treatment; Qualifying surgery cannot be for cancer.
•clinical sepsis (unstable bp despite pressor support AND MAP < 60 on at least 3 consecutive readings within a 3-hour period during the 24h prior to study entry)
•pregnancy
•history of seizure or pre-existing seizure disorder
•current encephalopathy
•known history of cirrhosis OR bili > 10
•history of CRF requiring dialysis, or significant renal dysfunction (cr >2.5 and not on CVVH or requiring HD postop)
•current burn or trauma injury
•previous organ transplant
•HIV/AIDS
•received any investigational drug within 60 days prior to study entry
•received enteral or parenteral feedings enriched with arginine or glutamine within 30 days prior to study entry