Status:
COMPLETED
Efficacy and Mechanisms of GLN Dipeptide in the SICU
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Critical Illness
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
Relative glutamine (GLN) deficiency may contribute to morbidity and mortality in surgical intensive care unit (SICU) patients. During critical illness, GLN utilization by the immune system, gut mucosa...
Detailed Description
Overview: Relative deficiency of glutamine (GLN) appears to contribute to morbidity and mortality in surgical intensive care unit (SICU) patients, but conventional nutrition support does not repair th...
Eligibility Criteria
Inclusion
- Inclusion criteria: 1) A signed informed consent is in place on the patient's chart; 2) The patient is at least 18 but not more than 90 years of age at time of surgery; 3) The patient has a body mass index (BMI) \< 40 kg/m2 prior to surgery; 4) The patient currently requires SICU care and is within 14 days postoperative from one of the following open (non-laparoscopic) surgical procedures: coronary artery bypass graft(CABG), cardiac valve, vascular (non-neurosurgical), or esophageal gastrointestinal resection of esophagus, stomach, small bowel, colon and/or rectum), or operation to identify the source of peritonitis when there is evidence of a bowel perforation (with or without bowel resection); 5) The patient will require central venous PN for 7+ subsequent days after entry on a clinical basis≠; 6) There is central venous access for administration of the study PN; and 7) The patient's primary physician(s) will allow the investigative team to manage the study PN and enteral feedings during the current hospitalization.
- Exclusion Criteria: 1) The patient is pregnant; 2) The patient has clinical sepsis \[defined as unstable blood pressure despite pressor support AND mean arterial pressure (MAP) \< 60 mm Hg on at least 3 consecutive readings within a 3-hour period during the 24 hours prior to study entry; 3) a) The patient has a current malignancy requiring surgery as the GLND qualifying operation OR b) the patient is currently receiving an active regimen of chemotherapy and/or radiotherapy to treat a previously diagnosed malignancy†; 4) The patient has a history of seizures or pre-existing seizure disorder; 5) The patient has a current encephalopathy\*; 6) The patient has a known history of cirrhosis OR a serum total bilirubin level ≥ 10.0 mg/dL); 7) The patient has a history of chronic renal failure requiring dialysis, or has significant renal dysfunction (defined as serum creatinine \> 2.5 mg/dL and is not receiving continuous renal replacement therapy (CRRT) or the patient requires acute hemodialysis postoperatively; 8) The patient has a concomitant burn or trauma injury; 9) The patient has previously undergone an organ transplantation;10) the patient has a history of HIV/AIDS; 11) The patient has received any investigational drug within 60 days prior to study entry; 12) The patient has received enteral or parenteral enteral feedings enriched in arginine and/or glutamine within 30 days prior to study entry; and 13) The patient is unable or unwilling to participate in study procedures such as longitudinal blood draws and out patient follow-up visits, etc.
- \*Encephalopathy for GLND can be diagnosed only in non-chemically sedated patients by the primary critical care physicians or neurologist consultants and is defined as either a comatose state OR severe abnormalities diagnosed by electroencephalogram (EEG), OR if all of the following criteria are met: a) patient goes to sleep but is arousable to verbal and painful stimuli; does not open eyes spontaneously (decreased level of consciousness); b) patient exhibits severe confusion or complete disorientation when aroused (disorientation); c) patient exhibits severe lethargy or bizarre behavior (behavioral dysfunction); and d) patient exhibits inability to cooperate, asterixis, ataxia, clonus, decortication, decerebration, seizures, or rigidity (severe neuromuscular dysfunction).
- † Patients with malignant metastasis and terminal untreatable carcinoma will be excluded as per the operational definition agreed upon by the Data Safety and Monitoring Board (DSMB).
- ≠ Please note that the patient should be in the SICU at the initial PN hang time.
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00248638
Start Date
September 1 2006
End Date
December 1 2012
Last Update
January 23 2018
Active Locations (5)
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1
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
2
Emory University
Atlanta, Georgia, United States, 30322
3
The Miriam Hospital/Brown University
Providence, Rhode Island, United States, 02906
4
Vanderbilt University
Nashville, Tennessee, United States, 37212-2713