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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-01

Study Completion Date

2014-12-31

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.

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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.

Conditions

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Critical Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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GA (glutamine and vitamin C) group

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).

Group Type EXPERIMENTAL

Glutamine and vitamin C enteral supplement

Intervention Type DIETARY_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.

Control (C) group

Placebo:

Subjects in the C group received isocaloric maltodextrin as placebo.

Group Type PLACEBO_COMPARATOR

Glutamine and vitamin C enteral supplement

Intervention Type DIETARY_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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No