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

Not Applicable

Recruiting

• Conditions: Pressure Ulcer
• Interventions: Dietary Supplement: alanyl-glutamine

• Registration Number: NCT05586646
• Lead Sponsor: Air Force Specialized Hospital, Cairo, Egypt

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.

Study Timeline

• Study Start: 2022-04-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-15
• Study First Submitted QC: 2022-10-15
• Last Update Submitted: 2022-10-15
• Study First Posted: 2022-10-19
• Last Update Posted: 2022-10-19
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alanyl-glutamine group	alanyl-glutamine	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).

Primary Outcome Measures

Name	Time	Method
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 proportion of viable wound tissue	2 weeks	Final proportion of viable wound tissue /original proportion of viable wound tissue x 100
Percentage change in pressure ulcer area	2 weeks	Final ulcer area/original ulcer area x 100

Trial Locations

Locations (1)

Air Force Specialized Hospital; 🇪🇬 Cairo, New Cairo, Egypt