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Trial record 20 of 562 for:    maltodextrin

Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02998931
Recruitment Status : Completed
First Posted : December 21, 2016
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Zahra Vahdat Shariatpanahi, Shahid Beheshti University

Brief Summary:
Glutamine supplementation has beneficial effects on morbidity and mortality in critically ill patients, possibly in part through an attenuation of the proinflammatory cytokine response and a Immune function. In this trial intensive care unit patients with enteral feeding will receive either enteral glutamine or maltodextrin as placebo for 28 days.

Condition or disease Intervention/treatment Phase
Critical Illness Enteral Nutrition Multiple Organ Failure Infection Complication Inflammation Drug: Glutamin Other: Maltodextrin Phase 3

Detailed Description:
A randomized, double blind, controlled trial will be conducted in general intensive care unit (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 200 eligible hospitalized patients with enteral feeding in ICU, aged ≥ 18 years. Intervention patients will be received 0.3 g/kg/day of glutamine along with enteral formula for 28 days and control patients will be received maltodextrin along with enteral formula for 28 days. Patients will be evaluated for occurrence of new infection, organ failure, duration of stay in ICU, 28 days and 6 months mortality and inflammatory and immune markers.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Enteral Glutamine on Inflammatory Response, Immune System Function and Clinical Outcomes in Hospitalized Patients With Enteral Feeding in Intensive Care Unit
Actual Study Start Date : November 10, 2016
Actual Primary Completion Date : August 25, 2018
Actual Study Completion Date : September 10, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine

Arm Intervention/treatment
Experimental: Glutamin
Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs.
Drug: Glutamin
Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs
Other Name: L-glutamine

Placebo Comparator: maltodextrin
Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.
Other: Maltodextrin
Maltodextrin mixed with water given via NG tube Q 4 hours




Primary Outcome Measures :
  1. Occurrence of infection [ Time Frame: Day 28 ]
    Incidence of infections


Secondary Outcome Measures :
  1. Serum Inflammatory Markers [ Time Frame: baseline, Day 5, Day 10 ]
    Inflammatory factors

  2. Serum Immunity Markers [ Time Frame: baseline, Day 5, Day 10 ]
  3. Length of stay in ICU [ Time Frame: Day 28 ]
  4. 28-day Mortality [ Time Frame: Day 28 ]
    Day 28

  5. 6-month mortality [ Time Frame: month 6 ]
    month 6


Other Outcome Measures:
  1. Serum Glutamin [ Time Frame: baseline, Day 5, Day 10 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (>18 years old) admitted to ICU
  • Start of study intervention within 48 hours after ICU admission
  • Expected to require enteral nutrition for at least 72 hours aiming for full enteral nutrition and receive at least 80 percent of enteral formula during the first 48 hour
  • Written informed consent of patient or written informed consent of legal representative

Exclusion Criteria:

  • Enrollment in a related ICU interventional study
  • Requiring other specific enteral nutrition for medical reason
  • Death or Discharge before 5th day
  • Having any contra-indication to receive enteral nutrition
  • Pregnant patients or lactating with the intent to breastfeed
  • Requiring other specific enteral nutrition for medical reason
  • BMI <18 or > 40.0 kg/m2
  • Have life expectancy of <6 mo
  • Patients who are moribond
  • Liver cirrhosis- Child's class C liver disease
  • Have seizure disorder requiring anticonvulsant
  • History of allergy or intolerance to the study product components
  • Receiving glutamine during two weeks before start study product
  • Have other reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998931


Locations
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Iran, Islamic Republic of
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences
Tehran, Iran, Islamic Republic of
Shohada Tajrish Hospital
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University
Investigators
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Study Chair: Zahra Vahdat Shariatpanahi, MD, PhD Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Publications:

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Responsible Party: Zahra Vahdat Shariatpanahi, Associate Professor, Shahid Beheshti University
ClinicalTrials.gov Identifier: NCT02998931     History of Changes
Other Study ID Numbers: 1395/670
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zahra Vahdat Shariatpanahi, Shahid Beheshti University:
Glutamin
Enteral Nutrition
Intensive Care Unit
Critical Care Outcomes
inflammatory
Immune System
Additional relevant MeSH terms:
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Inflammation
Critical Illness
Multiple Organ Failure
Pathologic Processes
Disease Attributes
Shock