Glutamine Supplementation and Short-term Mortality in Covid-19

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Covid19

Intervention / Treatment
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* Dietary Supplement: Standard enteral nutrition
* Combination Product: Glutamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group EN (standard enteral nutrition)<br>Patients receive standard enteral nutrition according to ICU nutrition protocol during 7days from admission | Dietary Supplement: Standard enteral nutrition<br>* Standard enteral nutrition according to ICU nutrition protocol for 7 days<br>|
| Experimental: Group GN (glutamine supplemented enteral nutrition)<br>Patients receive intravenous glutamine supplementation to enteral nutrition in a dose of glutamine of 0.4 g/kg/day during 7 days from admission. | Combination Product: Glutamine<br>* Intravenous glutamine supplementation to enteral nutrition in a dose of dose of glutamine of 0.4 g/kg/day for 7days<br>* Other names: Dipeptiven;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality | Short-term ICU mortality for patients admitted in our ICU & signed for study drugs, who will expire during the study | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutrophil/lymphocyte ratio (NLR) | Assessing NLR at day zero & day 7 to monitor inflammatory response | 7 days | 
| D- dimer level | Assessing D-dimer level at day zero &day 7 to monitor coagulability status | 7 days | 
| ICU stay | Period of patients admission in ICU within duration of study | 7 days |