Glutamine Supplementation and Short-term Mortality in Covid-19

Assiut University

Status and phase: Completed; Phase 3

Conditions: Covid19

Treatments: Dietary Supplement: Standard enteral nutrition; Combination Product: Glutamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04909905

17300609

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Group EN (standard enteral nutrition)

Experimental group

Description:

Patients receive standard enteral nutrition according to ICU nutrition protocol during 7days from admission

Treatment:

Dietary Supplement: Standard enteral nutrition

Group GN (glutamine supplemented enteral nutrition)

Experimental group

Description:

Patients receive intravenous glutamine supplementation to enteral nutrition in a dose of glutamine of 0.4 g/kg/day during 7 days from admission.

Treatment:

Combination Product: Glutamine