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

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05586646
• Other study ID #: 1234
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 2022

Study information

• Verified date: October 2022
• Source: Air Force Specialized Hospital, Cairo, Egypt
• Contact: Rana Hamed, Master
• Phone: 01002372975
• Email: ranona48[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

Dietary Supplement:
• alanyl-glutamine
Amino acid solution for parenteral nutrition containing dipeptide alanyl-glutamine

Locations

Country	Name	City	State
Egypt	Air Force Specialized Hospital	Cairo	New Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Specialized Hospital, Cairo, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in pressure ulcer length	Final ulcer length/original ulcer length x 100	2 weeks
Primary	Percentage change in pressure ulcer depth	Final ulcer depth/original ulcer depth x 100	2 weeks
Primary	Percentage change in pressure ulcer area	Final ulcer area/original ulcer area x 100	2 weeks
Primary	Percentage change in proportion of viable wound tissue	Final proportion of viable wound tissue /original proportion of viable wound tissue x 100	2 weeks