Effect of Glutamine and Vitamin C on Interleukin-6 and Clinical Outcomes in Surgical Intensive Care Unit Patients
- Conditions
- Critical Care
- Interventions
- Dietary Supplement: Glutamine and vitamin C enteral supplement
- Registration Number
- NCT03166956
- Lead Sponsor
- Chung Shan Medical University
- Brief Summary
Background \& Aims. Glutamine is a conditional essential amino acid that was found in reduced plasma amount in Intensive Care Unit (ICU) patients. The supplementations of glutamine and vitamin C potentially have beneficial effects on wound healing and a reduction in infection rate. In this investigation, enteral glutamine and vitamin C were provided for ICU patient, and the associated changes in proinflammatory cytokines and clinical outcomes were investigated.
- Detailed Description
Background \& Aims. Glutamine is a conditional essential amino acid that was found in reduced plasma amount in Intensive Care Unit (ICU) patients. The supplementation of glutamine in ICU patients has been under much debate. Another nutritional supplement, vitamin C, had a beneficial effect on wound healing and a reduction in infection rate. In this investigation, enteral glutamine and vitamin C were provided for ICU patient, and the associated changes in proinflammatory cytokines and clinical outcomes were investigated.
Methods. This is a prospective double-blind randomized study for surgical ICU patients whom can sustain enteral feeding. The test group was provided with glutamine and vitamin C (the GA group); the control (C) group was provided with maltodextrin of equivalent calories as that provided in the GA group. Plasma glutamine, interleukin-6 (IL-6), and clinical data were collected and analyzed with biostatistical methods.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- Between the ages 20 and 85 years
- Not enrolled in other clinical trials in the previous 1 month and during the study period
- Surgical ICU patients cared by the 9 participating surgeons
- Older than age 85 years
- Pregnant women
- With an abnormal liver function (receiving drugs or clinical therapies)
- Abnormal renal function (under hemodialysis)
- Multiple organ failure (more than 2 organs)
- Expected ICU stay of less than 72 hours
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GA (glutamine and vitamin C) group Glutamine and vitamin C enteral supplement Interventions of glutamine and vitamin C enteral supplementations were given to surgical intensive care unit (ICU) patients. Subjects in the GA group received enteral supplement of 10 g L-glutamine and 90 mg vitamin C per serving provided by Nutritec-Enjoy Nutrition Inc. (Taipei, Taiwan). Control (C) group Glutamine and vitamin C enteral supplement Placebo: Subjects in the C group received isocaloric maltodextrin as placebo.
- Primary Outcome Measures
Name Time Method Interleukin-6 Blood samples were collected for biochemical analyses on the starting day of enteral feeding (day of enrollment), and every 7 days until day of discharge from ICU, or on the day of discharge from ICU, which ever is shorter, assessed up to 14 days. Blood samples were collected for biochemical on the starting day of enteral feeding, and every 7 days or on the day of discharge from ICU.
Body mass index (BMI) At enrollment. body height and weight were taken and body mass index (BMI) calculated at baseline.
Acute Physiology and Chronic Health Evaluation II (APACHE II) score At enrollment. APACHE II score was calculated to classify the disease severity.
C reactive protein On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days. Hematological analyses
Interleukin-10 Blood samples were collected for biochemical analyses on the starting day of enteral feeding (day of enrollment), and every 7 days until day of discharge from ICU, or on the day of discharge from ICU, which ever is shorter, assessed up to 14 days. Blood samples were collected for biochemical on the starting day of enteral feeding, and every 7 days or on the day of discharge from ICU.
Plasma glutamine Blood samples were collected for biochemical analyses on the starting day of enteral feeding, and every 7 days or on the day of discharge from ICU, assessed up to 14 days. Blood was collected for analyses of plasma glutamine levels
Red blood cells On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days. Blood was collected for hematological analyses
Hemoglobin On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days. Blood was collected for hematological analyses
White blood cells On the starting day of enteral feeding (enrollment), and every 7 days or on the day of discharge from ICU, assessed up to 14 days. Hematological analyses
- Secondary Outcome Measures
Name Time Method Mortality in hospital stay Up to one year Clinical outcome
Length of ICU stay Up to one year Clinical outcome
Duration of ventilator use Up to one year Clinical outcome
ICU infectious complications Up to one year Clinical outcome
Mortality in ICU stay Up to one year Clinical outcome
Length of hospital stay Up to one year Clinical outcome