Glutamine Supplementation and Short-term Mortality in Covid-19

NCT ID: NCT04909905

Last Updated: 2021-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-30

Study Completion Date

2021-10-30

Brief Summary

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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

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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.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group EN (standard enteral nutrition)

Patients receive standard enteral nutrition according to ICU nutrition protocol during 7days from admission

Group Type EXPERIMENTAL

Standard enteral nutrition

Intervention Type DIETARY_SUPPLEMENT

Standard enteral nutrition according to ICU nutrition protocol for 7 days

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.

Group Type EXPERIMENTAL

Glutamine

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Standard enteral nutrition

Standard enteral nutrition according to ICU nutrition protocol for 7 days

Intervention Type DIETARY_SUPPLEMENT

Glutamine

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

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Dipeptiven

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Omar Makram Soliman

Lecturer of anesthesia and ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omar Soliman, MD

Role: PRINCIPAL_INVESTIGATOR

Omar makram

Locations

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Omar Soliman

Asyut, Assuit, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 32341077 (View on PubMed)

Other Identifiers

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17300609

Identifier Type: -

Identifier Source: org_study_id