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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pressure Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

alanyl-glutamine

Intervention Type DIETARY_SUPPLEMENT

Amino acid solution for parenteral nutrition containing dipeptide alanyl-glutamine

Interventions

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alanyl-glutamine

Amino acid solution for parenteral nutrition containing dipeptide alanyl-glutamine

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Dipeptiven

Eligibility Criteria

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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)

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No