Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02998931
Other study ID # 1395/670
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 10, 2016
Est. completion date September 10, 2018

Study information

Verified date October 2018
Source Shahid Beheshti University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date September 10, 2018
Est. primary completion date August 25, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Glutamin
Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs
Other:
Maltodextrin
Maltodextrin mixed with water given via NG tube Q 4 hours

Locations

Country Name City State
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

Sponsors (1)

Lead Sponsor Collaborator
Shahid Beheshti University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (6)

Hall JC, Dobb G, Hall J, de Sousa R, Brennan L, McCauley R. A prospective randomized trial of enteral glutamine in critical illness. Intensive Care Med. 2003 Oct;29(10):1710-6. Epub 2003 Aug 16. — View Citation

Heyland D, Muscedere J, Wischmeyer PE, Cook D, Jones G, Albert M, Elke G, Berger MM, Day AG; Canadian Critical Care Trials Group. A randomized trial of glutamine and antioxidants in critically ill patients. N Engl J Med. 2013 Apr 18;368(16):1489-97. doi: 10.1056/NEJMoa1212722. Erratum in: N Engl J Med. 2013 May 9;368(19):1853. Dosage error in article text.. — View Citation

Kreymann KG, Berger MM, Deutz NE, Hiesmayr M, Jolliet P, Kazandjiev G, Nitenberg G, van den Berghe G, Wernerman J; DGEM (German Society for Nutritional Medicine), Ebner C, Hartl W, Heymann C, Spies C; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Intensive care. Clin Nutr. 2006 Apr;25(2):210-23. Epub 2006 May 11. — View Citation

McClave SA, Taylor BE, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society for Parenteral and Enteral Nutrition. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):159-211. doi: 10.1177/0148607115621863. Erratum in: JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1200. — View Citation

McQuiggan M, Kozar R, Sailors RM, Ahn C, McKinley B, Moore F. Enteral glutamine during active shock resuscitation is safe and enhances tolerance of enteral feeding. JPEN J Parenter Enteral Nutr. 2008 Jan-Feb;32(1):28-35. — View Citation

van Zanten AR, Sztark F, Kaisers UX, Zielmann S, Felbinger TW, Sablotzki AR, De Waele JJ, Timsit JF, Honing ML, Keh D, Vincent JL, Zazzo JF, Fijn HB, Petit L, Preiser JC, van Horssen PJ, Hofman Z. High-protein enteral nutrition enriched with immune-modulating nutrients vs standard high-protein enteral nutrition and nosocomial infections in the ICU: a randomized clinical trial. JAMA. 2014 Aug 6;312(5):514-24. doi: 10.1001/jama.2014.7698. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Serum Glutamin baseline, Day 5, Day 10
Primary Occurrence of infection Incidence of infections Day 28
Secondary Serum Inflammatory Markers Inflammatory factors baseline, Day 5, Day 10
Secondary Serum Immunity Markers baseline, Day 5, Day 10
Secondary Length of stay in ICU Day 28
Secondary 28-day Mortality Day 28 Day 28
Secondary 6-month mortality month 6 month 6
See also
  Status Clinical Trial Phase
Completed NCT03995979 - Inflammation and Protein Restriction N/A
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT03577223 - Egg Effects on the Immunomodulatory Properties of HDL N/A
Completed NCT04383561 - Relationship Between LRG and Periodontal Disease N/A
Active, not recruiting NCT03622632 - Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT04856748 - Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
Completed NCT05529693 - Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population N/A
Recruiting NCT05670301 - Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases N/A
Recruiting NCT05415397 - Treating Immuno-metabolic Depression With Anti-inflammatory Drugs Phase 3
Recruiting NCT05775731 - Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
Recruiting NCT04543877 - WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study Early Phase 1
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Completed NCT03429920 - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors N/A
Completed NCT06065241 - Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals. N/A
Completed NCT05864352 - The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
Completed NCT03318731 - Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males N/A
Not yet recruiting NCT06134076 - Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota N/A
Not yet recruiting NCT06159543 - The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes N/A