Trial of Enteral Glutamine on Clinical Outcomes in Critic... | NCT02998931

Studies
Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients

NCT02998931

Sponsor

Shahid Beheshti University

Status

Completed

Last Update Posted

Oct 16, 2018Actual

Enrollment

200Actual

Phase

Phase 3

Conditions

Critical Illness
Enteral Nutrition
Multiple Organ Failure
Infection Complication
Inflammation

Interventions

Glutamin
Maltodextrin

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2016Actual

Primary Completion Date

Aug 25, 2018Actual

Completion Date

Sep 10, 2018Actual

First Submitted Date

Dec 14, 2016

First Submission Date that Met QC Criteria

Dec 16, 2016

First Posted Date

Dec 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2018

Last Update Posted Date

Oct 16, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glutamin	Experimental	Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs.	Drug: Glutamin
maltodextrin	Placebo Comparator	Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.	Other: Maltodextrin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glutamin	Drug	Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs	Glutamin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of infection	Incidence of infections	Day 28

Secondary Outcomes

Measure	Description	Time Frame
Serum Inflammatory Markers	Inflammatory factors	baseline, Day 5, Day 10
Serum Immunity Markers		baseline, Day 5, Day 10

Other Outcomes

Measure	Description	Time Frame
Serum Glutamin		baseline, Day 5, Day 10

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zahra Vahdat Shariatpanahi, MD, PhD	Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences		Tehran			Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25096691	Background	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.
23594003

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D012769	Shock

ID	Term
C020654	glutamin-(asparagin-)ase
D005973	Glutamine
C008315	maltodextrin

ID	Term
D024361	Amino Acids, Basic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000599	Amino Acids, Diamino

ID	Term
D016638	Critical Illness
D009102	Multiple Organ Failure
D007249	Inflammation