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Completed

NCT Number: NCT04909905

Glutamine Supplementation and Short-term Mortality in Covid-19

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Omar Soliman

Asyut, Assuit, Assuit universi, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard enteral nutrition

Dietary Supplement

Standard enteral nutrition according to ICU nutrition protocol for 7 days

Glutamine

Combination Product

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

Other names: Dipeptiven

Primary outcomes

  1. ICU mortality

    Time frame: 7 days

    Short-term ICU mortality for patients admitted in our ICU & signed for study drugs, who will expire during the study

Secondary outcomes

  1. Neutrophil/lymphocyte ratio (NLR)

    Time frame: 7 days

    Assessing NLR at day zero & day 7 to monitor inflammatory response

  2. D- dimer level

    Time frame: 7 days

    Assessing D-dimer level at day zero &day 7 to monitor coagulability status

  3. ICU stay

    Time frame: 7 days

    Period of patients admission in ICU within duration of study

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 2, 2021
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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