Keto-diet for Intubated Critical Care COVID-19

NCT04358835 | Withdrawn

• 1 other identifier: IRB00247383
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Coronavirus disease (COVID-2019) is a devastating viral illness that originated in Wuhan China in late 2019 and there are nearly 2 million confirmed cases. The mortality rate is approximately 5% of reported cases and over half of patients that require mechanical ventilation for respiratory failure. As the disease continues to spread, strategies for reducing duration of ventilator support in patients with COVID-19 could significantly reduce morbidity and mortality of these individuals and future patients requiring this severely limited life-saving resource. Methods to improve gas exchange and to reduce the inflammatory response in COVID-19 are desperately needed to save lives. The ketogenic diet is a high fat, low carbohydrate, adequate-protein diet that promotes metabolic ketosis (ketone body production) through hepatic metabolism of fatty acids. High fat, low carbohydrate diets have been shown to reduce duration of ventilator support and partial pressure carbon dioxide in patients with acute respiratory failure. In addition, metabolic ketosis reduces systemic inflammation. This mechanism could be leveraged to halt the cytokine storm characteristic of COVID-19 infection. The hypothesis of this study is that the administration of a ketogenic diet will improve gas exchange, reduce inflammation, and duration of mechanical ventilation. The plan is to enroll 15 intubated patients with COVID 19 infection and administer a 4:1 ketogenic formula during their intubation.

Conditions

COVID-19

Keywords

ketogenic diet; Intensive care; COVID-19; Mechanical ventilation; Intubated patients; coronavirus

Outcome Measures

Primary Outcomes (1)

• Change in the partial pressure of carbon dioxide (PaCO2)

  PaCO2 is the partial pressure of carbon dioxide Units: millimeters of mercury

  Daily until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days

Secondary Outcomes (34)

• Change in minute ventilation

  every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days

• Change in respiratory system compliance

  every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days

• Change in driving pressure

  every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days

• Change in ventilator synchrony

  every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days

• Change in mean arterial pressure

  every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days

Other Outcomes (22)

• Change in total blood cholesterol level

  At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days

• Change in blood low-density lipoprotein level

  At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days

• Change in blood high-density lipoprotein level

  At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days

Study Arms (1)

Intubated patients with COVID-19 on a ketogenic diet only

EXPERIMENTAL

4:1 ketogenic diet formula

Dietary Supplement: Ketogenic diet; Other: standard of care

Interventions

Ketogenic diet DIETARY_SUPPLEMENT

4:1 ratio enteral ketogenic formula within 48 hours of intubation

Intubated patients with COVID-19 on a ketogenic diet only

standard of care OTHER

standard of care/supportive therapy

Intubated patients with COVID-19 on a ketogenic diet only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18 and older.
• COVID-19 positive and respiratory failure requiring intubation
• Legally authorized representative

You may not qualify if:

• Unstable metabolic condition
• Liver failure
• Acute Pancreatitis
• Inability to tolerate enteral feeds, ileus, gastrointestinal bleeding
• Known Pregnancy
• Received propofol infusion within 24 hours
• Known fatty acid oxidation disorder or pyruvate carboxylase deficiency

Sponsors & Collaborators

• Johns Hopkins University: lead

Related Publications (33)

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Related Links

• Severe Outcomes Among Patients with Coronavirus Disease 2019 (COVID-19) - United States, February 12-March 16, 2020

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Diet, Ketogenic; Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mackenzie Cervenka, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-center, open-label, clinical trial designed to determine whether a ketogenic diet improves gas exchange and reduces ventilator requirements in patients with coronavirus disease intubated for respiratory failure. The study team will prospectively enroll 15 intubated patients with COVID-19 infection and administer a 4:1 ratio enteral ketogenic formula within 48 hours of intubation. This study will compare outcomes to a retrospective cohort of intubated patients with COVID-19 who did not receive ketogenic diet. As other clinical trials begin, co-administration of other therapies as well as standard care treatments will be recorded. In addition, the study will compare clinical outcomes with patients receiving exclusively standard clinical care.

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 24, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: December 31, 2021
• Last Updated: August 25, 2020

Record last verified: 2020-08