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Completed

NCT Number: NCT03166956

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

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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Key information

Conditions

Critical Care

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glutamine and vitamin C enteral supplement

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.

Primary outcomes

  1. Interleukin-6

    Time frame: 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.

    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.

  2. Interleukin-10

    Time frame: 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.

    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.

  3. Body mass index (BMI)

    Time frame: At enrollment.

    body height and weight were taken and body mass index (BMI) calculated at baseline.

  4. Acute Physiology and Chronic Health Evaluation II (APACHE II) score

    Time frame: At enrollment.

    APACHE II score was calculated to classify the disease severity.

  5. Plasma glutamine

    Time frame: 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.

    Blood was collected for analyses of plasma glutamine levels

  6. Red blood cells

    Time frame: 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.

    Blood was collected for hematological analyses

  7. Hemoglobin

    Time frame: 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.

    Blood was collected for hematological analyses

  8. White blood cells

    Time frame: 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.

    Hematological analyses

  9. C reactive protein

    Time frame: 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.

    Hematological analyses

Secondary outcomes

  1. Length of hospital stay

    Time frame: Up to one year

    Clinical outcome

  2. Length of ICU stay

    Time frame: Up to one year

    Clinical outcome

  3. Duration of ventilator use

    Time frame: Up to one year

    Clinical outcome

  4. ICU infectious complications

    Time frame: Up to one year

    Clinical outcome

  5. Mortality in ICU stay

    Time frame: Up to one year

    Clinical outcome

  6. Mortality in hospital stay

    Time frame: Up to one year

    Clinical outcome

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 25, 2017
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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