Glutamine Effects in Burn Patients

Drug Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05140772
• Other study ID #: 19/5/2019 ANET4
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: June 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: November 2021
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Effect

Intervention

Drug:
• Dipeptiven
IV administration daily for 7 days
• normal Saline
IV administration daily for 7 days

Locations

Country	Name	City	State
Egypt	Ashraf Magdy Eskandr	Shibeen Elkoom

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound culture test	whether +ve or -ve test	on 1,5,10 and 15 days after ICU admission
Secondary	Procalcitonin level	ng/ml	on 1,5,10 and 15 days after ICU admission
Secondary	CRP	mg/litre	on 1,5,10 and 15 days after ICU admission