Skip to main content
OpenTrials
Completed

NCT Number: NCT04957940

Lipid Emulsion Infusion and COVID-19 Patients

Investigators suggest that early administration of intravenous lipid emulsion (ILE) affect the inflammatory response and improve outcome in COVID-19. The aim of this trial is to study the effect of fish-oil-based intravenous lipid emulsion (FOBLE) supplementation added to enteral nutrition on shift to ICU for upgrading oxygenation &/or ventilation in moderate cases of Covid-19 diseased patients requiring only supplemental oxygen in form of simple nasal cannula or venturi mask oxygen (during 7 days admission).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Assiut university hospital

Asyut, Assuit, Assuit universi, Egypt

About this study

A written informed consent will be taken from the patients or their relatives. Patients will be randomly assigned to receive standard enteral nutrition plus 100 ml/day 0.9% normal saline at a rate 12.5 ml/h over 8 h for 5 days as the control group (Group C) or intravenous fish-oil-based lipid (SMOF lipid 20% which contains a unique 4-oil mix containing Soya bean, Medium-chain triglycerides, Olive oil and Fish oil) (Fresenius Kabi, Bad Homburg, Germany) emulsion supplementation to standard enteral nutrition (group L) in a dose of 100 ml/day at a rate of 12.5 ml/h over 8 h daily for 5 days.Finally, 20 mL of 0.9% normal saline was injected into the burette to flush the system. The entire apparatus was disposed of when each infusion was completed. The whole process was repeated for each infusion.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients are with diagnosis of moderate cases of covid-19 (a person who may have lower respiratory illness, such as pneumonia. However, their blood oxygen levels remain ≥94%)
  • Requiring only supplemental oxygen in form of simple nasal cannula or venturi mask oxygen admitted in the intermediate care attached to our ICU with good enteral nutrition.

Exclusion criteria

  • Hypersensitivity (peanut,eggs and soya bean)
  • Uncontrolled hyperlipidemia
  • Severe primary blood coagulation diseases
  • Acute pancreatitis
  • Acute thromboembolic diseases
  • Liver failure (bilirubin >40 mmol/l, alanine aminotransferase >100 U/l and aspartate aminotransferase >100 U/l)
  • RIFLE (Risk, Injury, Failure, Loss of kidney function and End-stage kidney disease) stage III and IV renal failure
  • Pregnancy or lactation
  • Severe neutropenia (<500 cells/mm3)

Treatment and study plan

SMOFlipid

Drug

Intravenous fish-oil-based lipid (SMOF lipid 20%) (Fresenius Kabi, Bad Homburg, Germany) emulsion supplementation to standard enteral nutrition in a dose of 100 ml/day at a rate of 12.5 ml/h over 8 h daily for 5 days.

0.9% saline

Other

Receive standard enteral nutrition plus 100 ml/day 0.9% normal saline at a rate 12.5 ml/h over 8 h for 5 days

Other names: Normal saline

Primary outcomes

  1. Shift of patients to ICU

    Time frame: 7 days

    Patients will be shifted to ICU for upgrading oxygenation &/or ventilation due to failed management in the intermediate care attached to our ICU (simple nasal cannula or venturi mask oxygen).According to the Chinese diagnosis and treatment guideline for COVID-19 (trial version 7.0), severe cases were defined as including one of the following criteria: (1) respiratory frequency >30/min, (2) oxygen saturation ≤93%, and (3) PO2/FiO2 ≤300 (taking consideration that severe ARDS PO2/FiO2 ratio < 100). Severe patients who need higher levels of oxygen support (high-flow nasal cannula HFNC or non invasive continuous positive airway pressure CPAP) to correct hypoxemia, or multiple organ dysfunction, are admitted to the ICU.

Secondary outcomes

  1. Percentage of short-term outcome

    Time frame: 7 days

    Assessing the percentage % of short-term outcome for cases admitted in the intermediate care attached to our ICU and numbers of patients either died, shifted to ICU for upgrading oxygenation and or ventilation or discharged to home.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Fish-Oil-Based Lipid Emulsion Infusion (FOBLE): Could Early Use Provide a Potential Therapy to Stop Moderate Cases of COVID-19 Diseased Patient's Shift to ICU?

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 12, 2021
Registry last updated
Sep 28, 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.

Published trials that share one or more normalized conditions with this study.