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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 covid19
Started May 2021
Shorter than P25 for phase_3 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2021
CompletedStudy Start
First participant enrolled
May 30, 2021
CompletedFirst Posted
Study publicly available on registry
June 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2021
CompletedNovember 5, 2021
November 1, 2021
5 months
May 30, 2021
November 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
ICU mortality
Short-term ICU mortality for patients admitted in our ICU \& signed for study drugs, who will expire during the study
7 days
Secondary Outcomes (3)
Neutrophil/lymphocyte ratio (NLR)
7 days
D- dimer level
7 days
ICU stay
7 days
Study Arms (2)
Group EN (standard enteral nutrition)
EXPERIMENTALPatients receive standard enteral nutrition according to ICU nutrition protocol during 7days from admission
Group GN (glutamine supplemented enteral nutrition)
EXPERIMENTALPatients receive intravenous glutamine supplementation to enteral nutrition in a dose of glutamine of 0.4 g/kg/day during 7 days from admission.
Interventions
Standard enteral nutrition according to ICU nutrition protocol for 7 days
Intravenous glutamine supplementation to enteral nutrition in a dose of dose of glutamine of 0.4 g/kg/day for 7days
Eligibility Criteria
You may qualify if:
- Diagnosis of covid-19 diseased patients admitted to the ICU with enteral nutrition.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Omar Soliman
Asyut, Assuit, Assuit universi, Egypt
Related Publications (1)
Mehta S. Nutritional status and COVID-19: an opportunity for lasting change? Clin Med (Lond). 2020 May 15;20(3):270-273. doi: 10.7861/clinmed.2020-0187.
PMID: 32341077BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Omar Soliman, MD
Omar makram
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of anesthesia and ICU
Study Record Dates
First Submitted
May 30, 2021
First Posted
June 2, 2021
Study Start
May 30, 2021
Primary Completion
October 25, 2021
Study Completion
October 30, 2021
Last Updated
November 5, 2021
Record last verified: 2021-11