Clinical trial NCT03166956: Effect of Glutamine and Vitamin C on Interleukin-6 and Clinical Outcomes in Surgical Intensive Care Unit Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Care
Keywords: Vitamin C
Glutamine
Interleukin-6
Clinical outcomes
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Interleukin-6
timeFrame: 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.
measure: Interleukin-10
timeFrame: 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.
measure: Body mass index (BMI)
timeFrame: At enrollment.
measure: Acute Physiology and Chronic Health Evaluation II (APACHE II) score
timeFrame: At enrollment.
measure: Plasma glutamine
timeFrame: 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.
measure: Red blood cells
timeFrame: 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.
measure: Hemoglobin
timeFrame: 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.
measure: White blood cells
timeFrame: 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.
measure: C reactive protein
timeFrame: 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 outcomes:
measure: Length of hospital stay
timeFrame: Up to one year
measure: Length of ICU stay
timeFrame: Up to one year
measure: Duration of ventilator use
timeFrame: Up to one year
measure: ICU infectious complications
timeFrame: Up to one year
measure: Mortality in ICU stay
timeFrame: Up to one year
measure: Mortality in hospital stay
timeFrame: Up to one year
Other outcomes:
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