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

Sponsor
Air Force Specialized Hospital, Cairo, Egypt (Other)
Overall Status
Recruiting
CT.gov ID
NCT05586646
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
8
Anticipated Duration (Months)
24.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: alanyl-glutamine
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model 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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of IV Alanyl Glutamine on Healing of Pressure Ulcers in Critically Ill Patients
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage change in pressure ulcer length [2 weeks]

      Final ulcer length/original ulcer length x 100

    2. Percentage change in pressure ulcer depth [2 weeks]

      Final ulcer depth/original ulcer depth x 100

    3. Percentage change in pressure ulcer area [2 weeks]

      Final ulcer area/original ulcer area x 100

    4. Percentage change in proportion of viable wound tissue [2 weeks]

      Final proportion of viable wound tissue /original proportion of viable wound tissue x 100

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Air Force Specialized Hospital Cairo New Cairo Egypt

    Sponsors and Collaborators

    • Air Force Specialized Hospital, Cairo, Egypt

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Air Force Specialized Hospital, Cairo, Egypt
    ClinicalTrials.gov Identifier:
    NCT05586646
    Other Study ID Numbers:
    • 1234
    First Posted:
    Oct 19, 2022
    Last Update Posted:
    Oct 19, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pressure Ulcer
    Ulcer

    Study Results

    No Results Posted as of Oct 19, 2022