Clinical trial NCT05586646: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pressure Ulcer
Lead sponsor: Air Force Specialized Hospital, Cairo, Egypt
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Percentage change in pressure ulcer length
timeFrame: 2 weeks
measure: Percentage change in pressure ulcer depth
timeFrame: 2 weeks
measure: Percentage change in pressure ulcer area
timeFrame: 2 weeks
measure: Percentage change in proportion of viable wound tissue
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Air Force Specialized Hospital
state: New Cairo
Study officials:
affiliation: Air Force Specialized Hospital
name: Enas Mogawer, Professor
role: STUDY_DIRECTOR
References: