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

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.

Study Overview

• Status: Recruiting
• Conditions: Pressure Ulcer
• Intervention / Treatment: Dietary supplement: 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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rana Hamed, Master; Phone Number: 01002372975; Email: ranona48@gmail.com

Study Locations

• Egypt
  • New Cairo
    • Cairo, New Cairo, Egypt
      • Recruiting
      • Air Force Specialized Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; 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; 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; Amino acid solution for parenteral nutrition containing dipeptide alanyl-glutamine; Other Names: Dipeptiven

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Air Force Specialized Hospital, Cairo, Egypt
• Investigators: Study Director: Enas Mogawer, Professor, Air Force Specialized Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 15, 2022
• First Submitted That Met QC Criteria: October 15, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 15, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: 1234 (Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No