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

NCT03166956 | Completed

• 1 other identifier: CS#12181
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Critical Care

Keywords

Vitamin C; Glutamine; Interleukin-6; Clinical outcomes

Outcome Measures

Primary Outcomes (9)

• 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.

• 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.

• Body mass index (BMI)

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

  At enrollment.

• Acute Physiology and Chronic Health Evaluation II (APACHE II) score

  APACHE II score was calculated to classify the disease severity.

  At enrollment.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (6)

• Length of hospital stay

  Up to one year

• Length of ICU stay

  Up to one year

• Duration of ventilator use

  Up to one year

• ICU infectious complications

  Up to one year

• Mortality in ICU stay

  Up to one year

Study Arms (2)

GA (glutamine and vitamin C) group

EXPERIMENTAL

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).

Dietary Supplement: Glutamine and vitamin C enteral supplement

Control (C) group

PLACEBO COMPARATOR

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

Dietary Supplement: Glutamine and vitamin C enteral supplement

Interventions

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.

Control (C) group; GA (glutamine and vitamin C) group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chung Shan Medical University: lead

MeSH Terms

Interventions

Glutamine

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chairman

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 25, 2017
• Study Start: June 1, 2012
• Primary Completion: August 31, 2014
• Study Completion: December 31, 2014
• Last Updated: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share