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

NCT05586646 | Unknown

• 1 other identifier: 1234
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcer

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

control group

NO INTERVENTION

100 critically ill patients will be enrolled on high protein diet either enteral or parenteral but not receiving any glutamine supplementations

alanyl-glutamine group

EXPERIMENTAL

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

Interventions

alanyl-glutamine DIETARY_SUPPLEMENT

Amino acid solution for parenteral nutrition containing dipeptide alanyl-glutamine

Also known as: Dipeptiven

alanyl-glutamine group

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with pressure ulcers stage 2,3 or 4, non-healing admitted to Air force specialized hospital for more than a week.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Air Force Specialized Hospital, Cairo, Egypt: lead

Study Sites (1)

Air Force Specialized Hospital

Cairo, New Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Interventions

alanylglutamine

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Enas Mogawer, Professor

  Air Force Specialized Hospital

  STUDY DIRECTOR

Central Study Contacts

Rana Hamed, Master

CONTACT

01002372975; ranona48@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: October 15, 2022
• First Posted: October 19, 2022
• Study Start: April 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)