Glutamine Effects in Burn Patients

NCT05140772 | Unknown Phase 2 DMC

• 1 other identifier: 19/5/2019 ANET4
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Effect

Outcome Measures

Primary Outcomes (1)

• wound culture test

  whether +ve or -ve test

  on 1,5,10 and 15 days after ICU admission

Secondary Outcomes (2)

• Procalcitonin level

  on 1,5,10 and 15 days after ICU admission

• CRP

  on 1,5,10 and 15 days after ICU admission

Study Arms (2)

group I

ACTIVE COMPARATOR

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

group II

PLACEBO COMPARATOR

Patients received an equivalent volume of normal saline daily for 7 days.

Drug: normal Saline

Interventions

Dipeptiven DRUG

IV administration daily for 7 days

group I

normal Saline DRUG

IV administration daily for 7 days

group II

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Ashraf Magdy Eskandr

Shibeen Elkoom, Egypt

Location

MeSH Terms

Interventions

alanylglutamine; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of anesthesia

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: December 1, 2021
• Study Start: June 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)