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Glutamine Supplementation and Short-term Mortality in Covid-19

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04909905
Enrollment
60
Registered
2021-06-02
Start date
2021-05-30
Completion date
2021-10-30
Last updated
2021-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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.

Interventions

DIETARY_SUPPLEMENTStandard enteral nutrition

Standard enteral nutrition according to ICU nutrition protocol for 7 days

COMBINATION_PRODUCTGlutamine

Intravenous glutamine supplementation to enteral nutrition in a dose of dose of glutamine of 0.4 g/kg/day for 7days

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ICU mortality7 daysShort-term ICU mortality for patients admitted in our ICU & signed for study drugs, who will expire during the study

Secondary

MeasureTime frameDescription
Neutrophil/lymphocyte ratio (NLR)7 daysAssessing NLR at day zero & day 7 to monitor inflammatory response
D- dimer level7 daysAssessing D-dimer level at day zero &day 7 to monitor coagulability status
ICU stay7 daysPeriod of patients admission in ICU within duration of study

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026