Glutamine Supplementation and Short-term Mortality in Covid-19

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04909905
• Other study ID #: 17300609
• Status: Completed
• Phase: Phase 3
• Start date: May 30, 2021
• Est. completion date: October 30, 2021

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 30, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Dietary Supplement:
• Standard enteral nutrition
Standard enteral nutrition according to ICU nutrition protocol for 7 days

Combination Product:
• Glutamine
Intravenous glutamine supplementation to enteral nutrition in a dose of dose of glutamine of 0.4 g/kg/day for 7days

Locations

Country	Name	City	State
Egypt	Omar Soliman	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Mehta S. Nutritional status and COVID-19: an opportunity for lasting change? Clin Med (Lond). 2020 Apr 27. pii: clinmed.2020-0187. doi: 10.7861/clinmed.2020-0187. [Epub ahead of print] — View Citation

Outcome

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