Glutamine Supplementation and Short-term Mortality in Covid-19

November 4, 2021 updated by: Omar Makram Soliman, Assiut University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Assuit
      • Assiut, Assuit, Egypt, Assuit universi
        • Omar Soliman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group EN (standard enteral nutrition)
Patients receive standard enteral nutrition according to ICU nutrition protocol during 7days from admission
Dietary supplement: Standard enteral nutrition
Standard enteral nutrition according to ICU nutrition protocol for 7 days
Experimental: Group GN (glutamine supplemented enteral nutrition)
Patients receive intravenous glutamine supplementation to enteral nutrition in a dose of glutamine of 0.4 g/kg/day during 7 days from admission.
Combination product: Glutamine
Intravenous glutamine supplementation to enteral nutrition in a dose of dose of glutamine of 0.4 g/kg/day for 7days
Other Names:
  • Dipeptiven

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Omar Soliman, MD, Omar makram

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2021

Primary Completion (Actual)

October 25, 2021

Study Completion (Actual)

October 30, 2021

Study Registration Dates

First Submitted

May 30, 2021

First Submitted That Met QC Criteria

June 1, 2021

First Posted (Actual)

June 2, 2021

Study Record Updates

Last Update Posted (Actual)

November 5, 2021

Last Update Submitted That Met QC Criteria

November 4, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17300609

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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