Effect of Glutamine and Vitamin C on Interleukin-6 and Clinical Outcomes in Surgical Intensive Care Unit Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Enteral Glutamine and Vitamin C Supplementation on Interleukin-6 and Clinical Outcomes in Surgical Intensive Care Unit Patients: A Prospective, Double-Blind, Randomized Controlled Trial

Conditions
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Critical Care

Intervention / Treatment
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* Dietary Supplement: Glutamine and vitamin C enteral supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GA (glutamine and vitamin C) group<br>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). | Dietary Supplement: Glutamine and vitamin C enteral supplement<br>* 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). Subjects in the C group received isocaloric maltodextrin as placebo.<br>|
| Placebo Comparator: Control (C) group<br>Placebo: Subjects in the C group received isocaloric maltodextrin as placebo. | Dietary Supplement: Glutamine and vitamin C enteral supplement<br>* 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). Subjects in the C group received isocaloric maltodextrin as placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin-6 | 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. | 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. | 
| Interleukin-10 | 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. | 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. | 
| Body mass index (BMI) | body height and weight were taken and body mass index (BMI) calculated at baseline. | At enrollment. | 
| Acute Physiology and Chronic Health Evaluation II (APACHE II) score | APACHE II score was calculated to classify the disease severity. | At enrollment. | 
| Plasma glutamine | Blood was collected for analyses of plasma glutamine levels | 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. | 
| Red blood cells | Blood was collected for hematological analyses | 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. | 
| Hemoglobin | Blood was collected for hematological analyses | 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. | 
| White blood cells | Hematological analyses | 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. | 
| C reactive protein | Hematological analyses | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Clinical outcome | Up to one year | 
| Length of ICU stay | Clinical outcome | Up to one year | 
| Duration of ventilator use | Clinical outcome | Up to one year | 
| ICU infectious complications | Clinical outcome | Up to one year | 
| Mortality in ICU stay | Clinical outcome | Up to one year | 
| Mortality in hospital stay | Clinical outcome | Up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin C, Glutamine, Interleukin-6, Clinical outcomes