Glutamine Effects in Burn Patients

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Drug Effect
• Intervention / Treatment: Drug: Dipeptiven; Drug: normal Saline

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Shibeen Elkoom, Egypt
    • Ashraf Magdy Eskandr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group I; 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; IV administration daily for 7 days
Placebo Comparator: group II; Patients received an equivalent volume of normal saline daily for 7 days.	Drug: normal Saline; IV administration daily for 7 days

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

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: November 21, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 21, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 19/5/2019 ANET4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will be available with after the end of the study when requested

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No