A Phase 2/3 interventional study of Dipeptiven and normal Saline in Drug Effect, sponsored by Menoufia University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-12-01.
Sponsored by Menoufia University · Phase 2/3, Interventional, and Treatment
The study is designed to evaluate the effect of parenteral glutamine supplementation on infection in burn patients.
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.
Menoufia University is the lead sponsor of 192 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Patients received an equivalent volume of normal saline daily for 7 days.
Drug: normal Saline
IV administration daily for 7 days
IV administration daily for 7 days
wound culture test
whether +ve or -ve test
Time frame: on 1,5,10 and 15 days after ICU admission
Procalcitonin level
ng/ml
Time frame: on 1,5,10 and 15 days after ICU admission
CRP
mg/litre
Time frame: on 1,5,10 and 15 days after ICU admission
Plan to share: No — Data will be available with after the end of the study when requested
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Menoufia University