Glutamine Effects in Burn Patients

NCT05140772 — Phase 2 / Phase 3, Unknown, 60 participants, Menoufia University

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Evaluations the Effect of Parenteral Glutamine on Reducing Infection Morbidity in Burn Patients in ICU. A Randomized Controlled Double-blind Study.

Registry	NCT05140772
Status	Unknown
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	60 (Actual)
Sponsor	Menoufia University (Other)
Conditions	Drug Effect
Interventions	Dipeptiven, normal Saline (Drug)
Dates	start 2020-06-01, primary completion 2021-12-01 (estimated), completion 2021-12-01 (estimated), first posted 2021-12-01, last updated 2021-12-01
Locations	1 site in Egypt

-Summary

The study is designed to evaluate the effect of parenteral glutamine supplementation on infection in burn patients.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
group I	Active comparator	Drug: Dipeptiven	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).
group II	Placebo comparator	Drug: normal Saline	Patients received an equivalent volume of normal saline daily for 7 days.

Dipeptiven (Drug): IV administration daily for 7 days
normal Saline (Drug): IV administration daily for 7 days

+Outcome measures

Primary outcomes

wound culture test [on 1,5,10 and 15 days after ICU admission]: whether +ve or -ve test

Secondary outcomes

Procalcitonin level [on 1,5,10 and 15 days after ICU admission]: ng/ml
CRP [on 1,5,10 and 15 days after ICU admission]: mg/litre

+Eligibility

Sex: All, ages: 18 Years to 50 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

+Locations (1)

Facility	City	Country	Status
Ashraf Magdy Eskandr	Shibeen Elkoom	Egypt