Effect of IV Alanyl Glutamine on Healing of Pressure Ulcers in Critically Ill Patients
Primary Purpose
Pressure Ulcer
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
alanyl-glutamine
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcer
Eligibility Criteria
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)
Sites / Locations
- Air Force Specialized HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
alanyl-glutamine group
Arm Description
100 critically ill patients will be enrolled on high protein diet either enteral or parenteral but not receiving any glutamine supplementations
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).
Outcomes
Primary Outcome Measures
Percentage change in pressure ulcer length
Final ulcer length/original ulcer length x 100
Percentage change in pressure ulcer depth
Final ulcer depth/original ulcer depth x 100
Percentage change in pressure ulcer area
Final ulcer area/original ulcer area x 100
Percentage change in proportion of viable wound tissue
Final proportion of viable wound tissue /original proportion of viable wound tissue x 100
Secondary Outcome Measures
Full Information
NCT ID
NCT05586646
First Posted
October 15, 2022
Last Updated
October 15, 2022
Sponsor
Air Force Specialized Hospital, Cairo, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT05586646
Brief Title
Effect of IV Alanyl Glutamine on Healing of Pressure Ulcers in Critically Ill Patients
Official Title
Effect of IV Alanyl Glutamine on Healing of Pressure Ulcers in Critically Ill Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Air Force Specialized Hospital, Cairo, Egypt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
100 critically ill patients will be enrolled on high protein diet either enteral or parenteral but not receiving any glutamine supplementations
Arm Title
alanyl-glutamine group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
alanyl-glutamine
Other Intervention Name(s)
Dipeptiven
Intervention Description
Amino acid solution for parenteral nutrition containing dipeptide alanyl-glutamine
Primary Outcome Measure Information:
Title
Percentage change in pressure ulcer length
Description
Final ulcer length/original ulcer length x 100
Time Frame
2 weeks
Title
Percentage change in pressure ulcer depth
Description
Final ulcer depth/original ulcer depth x 100
Time Frame
2 weeks
Title
Percentage change in pressure ulcer area
Description
Final ulcer area/original ulcer area x 100
Time Frame
2 weeks
Title
Percentage change in proportion of viable wound tissue
Description
Final proportion of viable wound tissue /original proportion of viable wound tissue x 100
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rana Hamed, Master
Phone
01002372975
Email
ranona48@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enas Mogawer, Professor
Organizational Affiliation
Air Force Specialized Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Air Force Specialized Hospital
City
Cairo
State/Province
New Cairo
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of IV Alanyl Glutamine on Healing of Pressure Ulcers in Critically Ill Patients
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