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

Critical Care Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03166956
• Other study ID #: CS#12181
• Status: Completed
• Phase: N/A
• First received: May 11, 2017
• Last updated: May 25, 2017
• Start date: June 1, 2012
• Est. completion date: December 31, 2014

Study information

• Verified date: May 2017
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 31, 2014
• Est. primary completion date: August 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Care

Intervention

Dietary Supplement:
• Glutamine and vitamin C enteral supplement
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	Body mass index (BMI)	body height and weight were taken and body mass index (BMI) calculated at baseline.	At enrollment.
Primary	Acute Physiology and Chronic Health Evaluation II (APACHE II) score	APACHE II score was calculated to classify the disease severity.	At enrollment.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Length of hospital stay	Clinical outcome	Up to one year
Secondary	Length of ICU stay	Clinical outcome	Up to one year
Secondary	Duration of ventilator use	Clinical outcome	Up to one year
Secondary	ICU infectious complications	Clinical outcome	Up to one year
Secondary	Mortality in ICU stay	Clinical outcome	Up to one year
Secondary	Mortality in hospital stay	Clinical outcome	Up to one year