Glutamine Supplementation and Short-term Mortality in Covid-19

NCT04909905 — Phase 3, Completed, 60 participants, Assiut University

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The Impact of Glutamine Supplementation Upon the Short-term Mortality of COVID-19 Diseased Patients Admitted in ICU: A Double Blind Randomized Clinical Trial

Registry	NCT04909905
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	60 (Actual)
Sponsor	Assiut University (Other)
Conditions	Covid19
Interventions	Standard enteral nutrition, Glutamine (Dietary supplement, combination product)
Dates	start 2021-05-30, primary completion 2021-10-25, completion 2021-10-30, first posted 2021-06-02, last updated 2021-11-05
Locations	1 site in Egypt

-Summary

The aim of this study is to investigate the effect of parenteral L-Glutamine supplementation added to enteral nutrition on short-term ICU mortality (7 days) in Covid-19 diseased patients.

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+Detailed description

A written informed consent will be taken from the patients or their relatives. Patients with diagnosis of covid-19 with enteral nutrition will be enrolled. Patients will be randomly assigned to receive either standard enteral nutrition (Group EN) or intravenous glutamine supplementation to enteral nutrition (group GN) in a dose of glutamine of 0.4 g/kg/day during ICU stay.

+Arms and interventions

Arm	Type	Interventions	Description
Group EN (standard enteral nutrition)	Experimental	Dietary Supplement: Standard enteral nutrition	Patients receive standard enteral nutrition according to ICU nutrition protocol during 7days from admission
Group GN (glutamine supplemented enteral nutrition)	Experimental	Combination Product: Glutamine	Patients receive intravenous glutamine supplementation to enteral nutrition in a dose of glutamine of 0.4 g/kg/day during 7 days from admission.

Standard enteral nutrition (Dietary supplement): Standard enteral nutrition according to ICU nutrition protocol for 7 days
Glutamine (Combination product), also known as Dipeptiven: Intravenous glutamine supplementation to enteral nutrition in a dose of dose of glutamine of 0.4 g/kg/day for 7days

+Outcome measures

Primary outcomes

ICU mortality [7 days]: Short-term ICU mortality for patients admitted in our ICU \& signed for study drugs, who will expire during the study

Secondary outcomes

Neutrophil/lymphocyte ratio (NLR) [7 days]: Assessing NLR at day zero \& day 7 to monitor inflammatory response
D- dimer level [7 days]: Assessing D-dimer level at day zero \&day 7 to monitor coagulability status
ICU stay [7 days]: Period of patients admission in ICU within duration of study

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Diagnosis of covid-19 diseased patients admitted to the ICU with enteral nutrition.

Exclusion Criteria:

* Renal failure (creatinine >180 mmol/l)
* Hepatic failure (bilirubin >40 mmol/l, alanine aminotransferase >100 U/l and aspartate aminotransferase >100 U/l)
* Severe neutropenia (<500 cells/mm3)
* Patients receiving cytotoxic, radiation and/or steroid therapy
* Hemodynamic instability

+Locations (1)

Facility	City	Country	Status
Omar Soliman	Asyut, Assuit	Egypt

+Publications

Mehta S. Nutritional status and COVID-19: an opportunity for lasting change? Clin Med (Lond). 2020 May 15;20(3):270-273. doi: 10.7861/clinmed.2020-0187. PMID 32341077

+Investigators

Omar Soliman, MD, Principal investigator, Omar makram