Pressure UlcerNCT05586646
Effect of IV Alanyl Glutamine on Healing of Pressure Ulcers in Critically Ill Patients
A study testing alanyl-glutamine in people with Pressure Ulcer, run by Air Force Specialized Hospital, Cairo, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- alanyl-glutamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pressure ulcers stage 2,3 or 4, non-healing admitted to Air force specialized hospital for more than a week.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Air Force Specialized Hospital
Cairo, New Cairo
About this study
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.
Read the 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.
- Conditions
- Pressure Ulcer
- Being tested
- alanyl-glutamine
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alanyl-glutamineDietary supplement
Also called Dipeptiven
Amino acid solution for parenteral nutrition containing dipeptide alanyl-glutamine
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: alanyl-glutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in pressure ulcer length
Final ulcer length/original ulcer length x 100
Measured: 2 weeks
Percentage change in pressure ulcer depth
Final ulcer depth/original ulcer depth x 100
Measured: 2 weeks
Percentage change in pressure ulcer area
Final ulcer area/original ulcer area x 100
Measured: 2 weeks
Percentage change in proportion of viable wound tissue
Final proportion of viable wound tissue /original proportion of viable wound tissue x 100
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start1 Apr 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Specialized Hospital, Cairo, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enas Mogawer, Professor, Study director, Air Force Specialized Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586646
- Sponsor's protocol ID
- 1234
- Status last verified
- Oct 2022
- First submitted
- 15 Oct 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of IV Alanyl Glutamine on Healing of Pressure Ulcers in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT05586646
- Acronym / sponsor ID
- 1234
- Conditions
- Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Air Force Specialized Hospital, Cairo, EgyptUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: alanyl-glutamine100 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). |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with pressure ulcers stage 2,3 or 4, non-healing admitted to Air force specialized hospital for more than a week.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alanyl-glutamineAlso: DipeptivenAmino acid solution for parenteral nutrition containing dipeptide alanyl-glutamine | Dietary supplement | alanyl-glutamine group |
Primary outcome
Percentage change in pressure ulcer length
Time frame: 2 weeks
Final ulcer length/original ulcer length x 100
Percentage change in pressure ulcer depth
Time frame: 2 weeks
Final ulcer depth/original ulcer depth x 100
Percentage change in pressure ulcer area
Time frame: 2 weeks
Final ulcer area/original ulcer area x 100
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enas Mogawer, Professor study director
Air Force Specialized Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alanyl-glutamine in people with Pressure Ulcer, run by Air Force Specialized Hospital, Cairo, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rana Hamed, Master (01002372975, ranona48@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in pressure ulcer length (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.