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

Chung Shan Medical University

Status: Completed

Conditions: Critical Care

Treatments: Dietary Supplement: Glutamine and vitamin C enteral supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT03166956

CS#12181

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

41 participants in 2 patient groups, including a placebo group

GA (glutamine and vitamin C) group

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Glutamine and vitamin C enteral supplement

Control (C) group

Placebo Comparator group

Description:

Placebo: Subjects in the C group received isocaloric maltodextrin as placebo.

Treatment:

Dietary Supplement: Glutamine and vitamin C enteral supplement