Drug EffectPhase 2/3NCT05140772
Glutamine Effects in Burn Patients
A Phase 2/3 study testing Dipeptiven and normal Saline in people with Drug Effect, run by Menoufia University at 1 site in Egypt.
Trial summary
The study is designed to evaluate the effect of parenteral glutamine supplementation on infection in burn patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Drug Effect
- What is being tested?
- Dipeptiven and normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 1 Dec 2021
- Phase
- Phase 2/3
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-50 years.
- Total burn surface area of 20% - 60%.
- Expected length of stay in ICU > 48 hr.
- Admission within 72 hrs of burn injury.
- Any thermal injury such as flame burns. Scald burns and contact burns.
Who cannot join
- Burn patients with hepatic failure.
- Burn patient with Severe renal failure (glomerular filtration rate (eGFR <50 ml/min).
- Patients with inborn errors of amino-acid metabolism (e.g., phenylketonuria).
- Burn patients with pre-existing severe cardiac, pulmonary diseases.
- Burn patients with diabetes mellitus or cancer.
- Patients with metabolic acidosis (pH<7.35).
- Electric burns.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluations the Effect of Parenteral Glutamine on Reducing Infection Morbidity in Burn Patients in ICU. A Randomized Controlled Double-blind Study.
The study is designed to evaluate the effect of parenteral glutamine supplementation on infection in burn patients.
Read the detailed description
Despite improvements in prevention and management, burn injury continues to represent a major threat to the health and welfare of people worldwide in all age groups. Even with early surgical intervention and aggressive antibiotic therapy, infectious complications are a major cause of death in severe burn injury, accounting for 75% of all deaths occurring after initial resuscitation.
It is proposed that one source of these infections is a translocation of gram-negative bacteria from the gut. However, this mechanism of bacterial translocation through the gut wall remains a controversial mechanism of infection in humans. In animal studies, it has been demonstrated that glutamine supplementation can decrease gut-derived bacterial translocation and improve outcomes from burn injury.
Whether this holds true in humans has to be evaluated by additional studies. A recent study concluded that glutamine supplementation reduces gram-negative bacteremia in burned patients but viewed itself as preliminary and suggested that more clinical trials are warranted to corroborate the study outcome.
- Conditions
- Drug Effect
- Being tested
- Dipeptiven, normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DipeptivenDrug
IV administration daily for 7 days
normal SalineDrug
IV administration daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| group I | Active comparator | Patient were received 0.5gm/kg/day IV glutamine infusion (dipeptiven 100ml contains 20 g N(2)-L-alanyl-L-glutamine (= 8.20 g L-alanine, 13.46 g L-glutamine) Water for Injections). Receives: Drug: Dipeptiven |
| group II | Placebo comparator | Patients received an equivalent volume of normal saline daily for 7 days. Receives: Drug: normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound culture test
whether +ve or -ve test
Measured: on 1,5,10 and 15 days after ICU admission
Secondary outcomes (2)
Procalcitonin level
ng/ml
Measured: on 1,5,10 and 15 days after ICU admission
CRP
mg/litre
Measured: on 1,5,10 and 15 days after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Jun 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug EffectStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ashraf magdy eskandr, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140772
- Sponsor's protocol ID
- 19/5/2019 ANET4
- Status last verified
- Nov 2021
- First submitted
- 19 Oct 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available with after the end of the study when requested
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluations the Effect of Parenteral Glutamine on Reducing Infection Morbidity in Burn Patients in ICU. A Randomized Controlled Double-blind Study.
- ClinicalTrials.gov ID
- NCT05140772
- Acronym / sponsor ID
- 19/5/2019 ANET4
- Conditions
- Drug Effect
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 1 Dec 2021 (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.
The study is designed to evaluate the effect of parenteral glutamine supplementation on infection in burn patients.
Detailed description
Despite improvements in prevention and management, burn injury continues to represent a major threat to the health and welfare of people worldwide in all age groups. Even with early surgical intervention and aggressive antibiotic therapy, infectious complications are a major cause of death in severe burn injury, accounting for 75% of all deaths occurring after initial resuscitation.
It is proposed that one source of these infections is a translocation of gram-negative bacteria from the gut. However, this mechanism of bacterial translocation through the gut wall remains a controversial mechanism of infection in humans. In animal studies, it has been demonstrated that glutamine supplementation can decrease gut-derived bacterial translocation and improve outcomes from burn injury.
Whether this holds true in humans has to be evaluated by additional studies. A recent study concluded that glutamine supplementation reduces gram-negative bacteremia in burned patients but viewed itself as preliminary and suggested that more clinical trials are warranted to corroborate the study outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I | Active comparator | Drug: DipeptivenPatient were received 0.5gm/kg/day IV glutamine infusion (dipeptiven 100ml contains 20 g N(2)-L-alanyl-L-glutamine (= 8.20 g L-alanine, 13.46 g L-glutamine) Water for Injections). |
| group II | Placebo comparator | Drug: normal SalinePatients received an equivalent volume of normal saline daily for 7 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18-50 years.
- Total burn surface area of 20% - 60%.
- Expected length of stay in ICU > 48 hr.
- Admission within 72 hrs of burn injury.
- Any thermal injury such as flame burns. Scald burns and contact burns.
Key exclusion criteria (7 listed)
- Burn patients with hepatic failure.
- Burn patient with Severe renal failure (glomerular filtration rate (eGFR <50 ml/min).
- Patients with inborn errors of amino-acid metabolism (e.g., phenylketonuria).
- Burn patients with pre-existing severe cardiac, pulmonary diseases.
- Burn patients with diabetes mellitus or cancer.
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 |
|---|---|---|
| DipeptivenIV administration daily for 7 days | Drug | group I |
| normal SalineIV administration daily for 7 days | Drug | group II |
Primary outcome
wound culture test
Time frame: on 1,5,10 and 15 days after ICU admission
whether +ve or -ve test
2 secondary outcomes
Procalcitonin level
Time frame: on 1,5,10 and 15 days after ICU admission
CRP
Time frame: on 1,5,10 and 15 days after ICU admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: No. Data will be available with after the end of the study when requested
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dipeptiven and normal Saline in people with Drug Effect, run by Menoufia University 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 5 inclusion and 7 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 1 Dec 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound culture test (time frame: on 1,5,10 and 15 days after ICU admission). 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 1 Dec 2021.