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

Air Force Specialized Hospital, Cairo, Egypt

Status: Enrolling

Conditions: Pressure Ulcer

Treatments: Dietary Supplement: alanyl-glutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT05586646

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Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

control group

No Intervention group

Description:

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 group

Description:

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).

Treatment:

Dietary Supplement: alanyl-glutamine