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

October 15, 2022 updated by: Air Force Specialized Hospital, Cairo, Egypt
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 2 weeks
Final ulcer length/original ulcer length x 100
2 weeks
Percentage change in pressure ulcer depth
Time Frame: 2 weeks
Final ulcer depth/original ulcer depth x 100
2 weeks
Percentage change in pressure ulcer area
Time Frame: 2 weeks
Final ulcer area/original ulcer area x 100
2 weeks
Percentage change in proportion of viable wound tissue
Time Frame: 2 weeks
Final proportion of viable wound tissue /original proportion of viable wound tissue x 100
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Specialized Hospital, Cairo, Egypt

Investigators

  • Study Director: Enas Mogawer, Professor, Air Force Specialized Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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