Pressure Ulcer
Conditions
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.
Interventions
DIETARY_SUPPLEMENTalanyl-glutamine
Amino acid solution for parenteral nutrition containing dipeptide alanyl-glutamine
Sponsors
Air Force Specialized Hospital, Cairo, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in pressure ulcer length | 2 weeks | Final ulcer length/original ulcer length x 100 |
| Percentage change in pressure ulcer depth | 2 weeks | Final ulcer depth/original ulcer depth x 100 |
| Percentage change in pressure ulcer area | 2 weeks | Final ulcer area/original ulcer area x 100 |
| Percentage change in proportion of viable wound tissue | 2 weeks | Final proportion of viable wound tissue /original proportion of viable wound tissue x 100 |
Countries
Egypt
Contacts
Primary ContactRana Hamed, Master
Outcome results
None listed