Glutamine Supplementation and Short-term Mortality in Covid-19

Phase 3

Completed

• Conditions: Covid19
• Interventions: Dietary Supplement: Standard enteral nutrition; Combination Product: Glutamine

• Registration Number: NCT04909905
• Lead Sponsor: Assiut University

Brief 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.

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.

Study Timeline

• Study Start: 2021-05-30
• Study First Submitted: 2021-05-30
• Study First Submitted QC: 2021-06-01
• Study First Posted: 2021-06-02
• Primary Completion: 2021-10-25
• Study Completion: 2021-10-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-04
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group EN (standard enteral nutrition)	Standard enteral nutrition	Patients receive standard enteral nutrition according to ICU nutrition protocol during 7days from admission
Group GN (glutamine supplemented enteral nutrition)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Omar Soliman; 🇪🇬 Assiut, Assuit, Egypt