Glutamine Effects in Burn Patients

Menoufia University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Drug Effect

Treatments: Drug: Dipeptiven; Drug: normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05140772

19/5/2019 ANET4

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

group I

Active Comparator group

Description:

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).

Treatment:

Drug: Dipeptiven

group II

Placebo Comparator group

Description:

Patients received an equivalent volume of normal saline daily for 7 days.

Treatment:

Drug: normal Saline