Glutamine Effects in Burn Patients

Phase 2

• Conditions: Drug Effect
• Interventions: Drug: Dipeptiven; Drug: normal Saline

• Registration Number: NCT05140772
• Lead Sponsor: Menoufia University

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.

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2021-10-19
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-21
• Last Update Submitted: 2021-11-21
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Study First Posted: 2021-12-01
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group I	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	normal Saline	Patients received an equivalent volume of normal saline daily for 7 days.

Primary Outcome Measures

Name	Time	Method
wound culture test	on 1,5,10 and 15 days after ICU admission	whether +ve or -ve test

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ashraf Magdy Eskandr; 🇪🇬 Shibeen Elkoom, Egypt