Effect of IV Alanyl Glutamine on Healing of Pressure Ulcers in Critically Ill Patients

Study Overview
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Brief Summary
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In this clinical trial, we will assess pressure ulcer healing rates in critically ill patients supplemented with IV Alanyl-Glutamine in comparison with critically ill patients not supplemented with alanyl-glutamine.

Detailed Description
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This clinical trial will include 200 Egyptian Critically ill patients with bed sores equal or more than grade II selected from ward or ICU at Air Force specialized Hospital. They will be classified into 2 groups: Group I: 100 critically ill patients will be enrolled on high protein diet and receiving IV alanyl Glutamine with dose 0.3 gm/kg/ day which equal 1.5 ml/kg/day of alanyl-glutamine until discharge from ICU, death (with duration of 2 weeks administration). Group II: 100 critically ill patients will be enrolled on high protein diet either enteral or parenteral but not receiving any glutamine supplementations.

Official Title
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Effect of IV Alanyl Glutamine on Healing of Pressure Ulcers in Critically Ill Patients

Conditions
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Pressure Ulcer

Intervention / Treatment
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* Dietary Supplement: alanyl-glutamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with pressure ulcers stage 2,3 or 4, non-healing admitted to Air force specialized hospital for more than a week. Exclusion Criteria: Patients with renal impairment (GFR </= 30) Patients who require fluid restriction < 1 Litre/day. Patients with liver cirrhosis. (Child B and C) Length of stay< 2 weeks. Patients with deep tissue infection and/or requiring debridement of necrotic or sloughy tissue. Hemodynamically unstable patients. (On high dose of cardiac supports)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This clinical trial will include 200 Egyptian Critically ill patients with bed sores equal or more than grade II selected from ward or ICU at Air Force specialized Hospital. They will be classified into 2 groups: Group I: 100 critically ill patients will be enrolled on high protein diet and receiving IV alanyl Glutamine with dose 0.3 gm/kg/ day which equal 1.5 ml/kg/day of alanyl-glutamine until discharge from ICU, death (with duration of 2 weeks administration). Group II: 100 critically ill patients will be enrolled on high protein diet either enteral or parenteral but not receiving any glutamine supplementations.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>100 critically ill patients will be enrolled on high protein diet either enteral or parenteral but not receiving any glutamine supplementations | |
| Experimental: alanyl-glutamine group<br>100 critically ill patients will be enrolled on high protein diet and receiving IV alanyl Glutamine with dose 0.3 gm/kg/ day which equal 1.5 ml/kg/day of alanyl-glutamine until discharge from ICU, death (with duration of 2 weeks administration). | Dietary Supplement: alanyl-glutamine<br>* Amino acid solution for parenteral nutrition containing dipeptide alanyl-glutamine<br>* Other names: Dipeptiven;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in pressure ulcer length | Final ulcer length/original ulcer length x 100 | 2 weeks | 
| Percentage change in pressure ulcer depth | Final ulcer depth/original ulcer depth x 100 | 2 weeks | 
| Percentage change in pressure ulcer area | Final ulcer area/original ulcer area x 100 | 2 weeks | 
| Percentage change in proportion of viable wound tissue | Final proportion of viable wound tissue /original proportion of viable wound tissue x 100 | 2 weeks |