Back to resultsGlutamine Supplementation and Short-term Mortality in Covid-19
Primary Purpose
Covid19
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Standard enteral nutrition
Glutamine
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
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
Sites / Locations
- Omar Soliman
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group EN (standard enteral nutrition)
Group GN (glutamine supplemented enteral nutrition)
Arm Description
Patients receive standard enteral nutrition according to ICU nutrition protocol during 7days from admission
Patients receive intravenous glutamine supplementation to enteral nutrition in a dose of glutamine of 0.4 g/kg/day during 7 days from admission.
Outcomes
Primary Outcome Measures
ICU mortality
Short-term ICU mortality for patients admitted in our ICU & signed for study drugs, who will expire during the study
Secondary Outcome Measures
Neutrophil/lymphocyte ratio (NLR)
Assessing NLR at day zero & day 7 to monitor inflammatory response
D- dimer level
Assessing D-dimer level at day zero &day 7 to monitor coagulability status
ICU stay
Period of patients admission in ICU within duration of study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04909905
Brief Title
Glutamine Supplementation and Short-term Mortality in Covid-19
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 30, 2021 (Actual)
Primary Completion Date
October 25, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group EN (standard enteral nutrition)
Arm Type
Experimental
Arm Description
Patients receive standard enteral nutrition according to ICU nutrition protocol during 7days from admission
Arm Title
Group GN (glutamine supplemented enteral nutrition)
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard enteral nutrition
Intervention Description
Standard enteral nutrition according to ICU nutrition protocol for 7 days
Intervention Type
Combination Product
Intervention Name(s)
Glutamine
Other Intervention Name(s)
Dipeptiven
Intervention Description
Intravenous glutamine supplementation to enteral nutrition in a dose of dose of glutamine of 0.4 g/kg/day for 7days
Primary Outcome Measure Information:
Title
ICU mortality
Description
Short-term ICU mortality for patients admitted in our ICU & signed for study drugs, who will expire during the study
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Neutrophil/lymphocyte ratio (NLR)
Description
Assessing NLR at day zero & day 7 to monitor inflammatory response
Time Frame
7 days
Title
D- dimer level
Description
Assessing D-dimer level at day zero &day 7 to monitor coagulability status
Time Frame
7 days
Title
ICU stay
Description
Period of patients admission in ICU within duration of study
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Soliman, MD
Organizational Affiliation
Omar makram
Official's Role
Principal Investigator
Facility Information:
Facility Name
Omar Soliman
City
Assiut
State/Province
Assuit
ZIP/Postal Code
Assuit universi
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32341077
Citation
Mehta S. Nutritional status and COVID-19: an opportunity for lasting change? Clin Med (Lond). 2020 Apr 27;20(3):270-3. doi: 10.7861/clinmed.2020-0187. Online ahead of print.
Results Reference
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Learn more about this trial
Glutamine Supplementation and Short-term Mortality in Covid-19
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