Glutamine Effects in Burn Patients

Study Overview
=================
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.

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

Conditions
-----------------
Drug Effect

Intervention / Treatment
-----------------
* Drug: Dipeptiven
* Drug: normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group I<br>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). | Drug: Dipeptiven<br>* IV administration daily for 7 days<br>|
| Placebo Comparator: group II<br>Patients received an equivalent volume of normal saline daily for 7 days. | Drug: normal Saline<br>* IV administration daily for 7 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound culture test | whether +ve or -ve test | on 1,5,10 and 15 days after ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procalcitonin level | ng/ml | on 1,5,10 and 15 days after ICU admission | 
| CRP | mg/litre | on 1,5,10 and 15 days after ICU admission |