Drug Effect
Conditions
Brief summary
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.
Interventions
DRUGDipeptiven
IV administration daily for 7 days
DRUGnormal Saline
IV administration daily for 7 days
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| wound culture test | on 1,5,10 and 15 days after ICU admission | whether +ve or -ve test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CRP | on 1,5,10 and 15 days after ICU admission | mg/litre |
| Procalcitonin level | on 1,5,10 and 15 days after ICU admission | ng/ml |
Countries
Egypt
Outcome results
None listed