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Keto-diet for Intubated Critical Care COVID-19 (KICC-COVID19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04358835
Recruitment Status : Withdrawn (Study did not begin enrollment, multiple competing studies at same institution)
First Posted : April 24, 2020
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.


Condition or disease Intervention/treatment Phase
COVID-19 Dietary Supplement: Ketogenic diet Other: standard of care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Keto-diet for Intubated Critical Care COVID-19 (KICC-COVID19)
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care

Arm Intervention/treatment
Experimental: Intubated patients with COVID-19 on a ketogenic diet only
4:1 ketogenic diet formula
Dietary Supplement: Ketogenic diet
4:1 ratio enteral ketogenic formula within 48 hours of intubation

Other: standard of care
standard of care/supportive therapy




Primary Outcome Measures :
  1. Change in the partial pressure of carbon dioxide (PaCO2) [ Time Frame: Daily until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    PaCO2 is the partial pressure of carbon dioxide Units: millimeters of mercury


Secondary Outcome Measures :
  1. Change in minute ventilation [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Minute ventilation is the product of respiratory rate and tidal volume. Units: Liter per minute

  2. Change in respiratory system compliance [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]

    Respiratory system compliance measures the extent to which the lungs will expand.

    In a ventilated patient, compliance can be measured by dividing the delivered tidal volume by the [plateau pressure minus the total peep]. Units: liter/centimeter of water


  3. Change in driving pressure [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Driving pressure is a measure of the strain applied to the respiratory system and the risk of ventilator-induced lung injuries Driving pressure = Plateau pressure - Total Positive end-expiratory pressure (PEEP) Units: centimeter of water

  4. Change in ventilator synchrony [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Ventilator synchrony is the match between the patient's neural inspiratory time and the ventilator insufflation time

  5. Change in mean arterial pressure [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Mean arterial pressure is the average pressure in a patient's arteries during one cardiac cycle. Mean arterial pressure = diastolic blood pressure +[1/3(systolic blood pressure - diastolic blood pressure)] Units: millimeter of mercury

  6. Change in the fraction of inspired oxygen percentage of oxygen (FiO2) [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]

    FiO2: Fraction of Inspired Oxygen Percentage of oxygen in the air mixture that is delivered to the patient.

    Units: %


  7. Change in the partial pressure of carbon dioxide (PaO2) to the fraction of inspired oxygen percentage of oxygen (FiO2) ratio [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]

    PaO2/FiO2 ratio is the ratio of arterial oxygen partial pressure (PaO2) to fractional inspired oxygen.

    Units: millimeter of mercury


  8. Change in hydrogen ion activity (pH) [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    pH measures hydrogen ion activity. It is a conventional part of every arterial blood gas determination pH: no units.

  9. Change in Bicarbonate (HCO3) [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Bicarbonate is a conventional part of every arterial blood gas determination Units: milliequivalents/Liter

  10. Change in red blood cell count [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Red blood cell count measure anemia or hypoglycemia. Units: cells per liter

  11. Change in white blood cell count [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    White blood cell count evaluates leukopenia or leukocytosis. Units: cells/liter

  12. Change in white cell differential [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    White cell differential shows the amount of neutrophils, lymphocytes, basophils, eosinophils and may give some clue of the type of infection. Units: %

  13. Change in hemoglobin levels [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Hemoglobin is an indirect way to measure red blood cells. Units: gram/deciliter

  14. Change in hematocrit [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Hematocrit measures the volume percentage of red blood cells in blood. Units: %

  15. Change in mean cell volume [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Mean cell volume is a measure of the average volume of a red blood corpuscle. Units: femtoliters

  16. Change in mean cell hemoglobin [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Mean cell hemoglobin is the average mass of hemoglobin per red blood cell in a sample of blood. Units: picograms

  17. Change in mean cell hemoglobin concentration [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Mean cell hemoglobin concentration is the average concentration of hemoglobin in a given volume of blood. Units: %

  18. Change in platelet count [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Platelet count measures the number of platelets in the blood and determines thrombocytopenia or thrombocytosis. Units: platelets/liter

  19. Change in red cell distribution width [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Red cell distribution width is a measure of the range of variation of red blood cell volume. Units: no units

  20. Change in blood albumin level [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Liver function test Units: gram/deciliter

  21. Change in serum alkaline phosphatase level [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Liver function test Units: international units/liter

  22. Change in serum aspartate transaminase level [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Liver function test Units: international units/liter

  23. Change in serum alanine aminotransferase level [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Liver function test Units: international units/liters

  24. Change in blood urea nitrogen levels [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Kidney function test Units: milligram/deciliter

  25. Change in serum calcium level [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Kidney function test Units: milligram/deciliter

  26. Change in serum chloride level [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Kidney function test Units: millimole/liter

  27. Change in serum potassium level [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Kidney function test Units: millimole/liter

  28. Change in serum creatinine level [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Kidney function test Units: gram/deciliter

  29. Date patient is re-intubated or need mechanical ventilation for a second time [ Time Frame: Up to 10 days ]
    If the patient needs mechanical ventilation for a second time, this information will be collected.

  30. Length of intensive care unit stay [ Time Frame: Up to 10 days ]
    Time from intensive care unit admission until death or transfer to hospital bed.

  31. The total hospital stay [ Time Frame: Up to 10 days ]
    Time from hospital admission to discharge from the hospital. This information will be collected.

  32. Disposition at discharge [ Time Frame: Up to 10 days ]
    Once the patient feels better and can leave the hospital, he/she will be discharged. The place of discharge (e.g. home, rehab facility, nursing home, etc), time and date will be collected.

  33. Change in heart rate [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Heart rate: is the number of times a person's heart beats per minute

  34. Change in the dosage of vasopressor medication [ Time Frame: every 6 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Units: milligram


Other Outcome Measures:
  1. Change in total blood cholesterol level [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Units: milligram/deciliter

  2. Change in blood low-density lipoprotein level [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Units: milligram/deciliter

  3. Change in blood high-density lipoprotein level [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Units: milligram/deciliter

  4. Change in blood triglycerides level [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Units: milligram/deciliter

  5. Change in blood glucose level [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Glucose: sugar in blood. Units: millimole/liter

  6. Change in blood glucagon level [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Glucagon: hormone release by pancreas that increase concentration of glucose in blood. Units: nanogram/liter

  7. Change in blood free fatty acids level [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Free fatty acids are fatty acids that are produced from triglycerides and are measure in blood.

  8. Change in blood insulin levels [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Hormone that regulates glucose. Units: insulin units/liter

  9. Change in blood leptin levels [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Leptin helps regulate and alter long-term food intake and energy expenditure. Units: nanogram/deciliter

  10. Change in blood insulin like growth factor 1 levels [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Units: nanomole/liter

  11. Change in blood C-reactive protein levels [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    C-reactive protein is a protein made by the liver that measures inflammation (e.g. pancreatitis). Units: microgram/milliliter

  12. Change in blood interleukin-1β levels [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Cytokines are signaling molecules that measure inflammation.

  13. Change in blood interleukin-6 levels [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Cytokines are signaling molecules that measure inflammation.

  14. Change in blood interleukin-18 levels [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Cytokines are signaling molecules that measure inflammation.

  15. Change in blood tumor necrosis factor alpha levels [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Cytokines are signaling molecules that measure inflammation.

  16. Change in blood C-C motif chemokine ligand 2 (CCL2) levels [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Chemokine that mediates inflammation.

  17. Change in blood C-C motif chemokine ligand 3 (CCL3) levels [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Chemokine that mediates inflammation.

  18. Change in blood C-C motif chemokine ligand 4 (CCL4) levels [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Chemokine that mediates inflammation.

  19. Change in blood B cell-attracting chemokine 1 (CXCL13) levels [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Chemokine that mediates inflammation.

  20. Change in blood ferritin levels [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Ferritin stores iron inside of cells. Units: nanogram/milliliter

  21. Change in blood betahydroxybutyrate levels [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Units: millimole/liter

  22. Change in blood urine acetoacetate levels [ Time Frame: At baseline and every 24 hours until the patient is wean off the ventilator or die, whichever came first, assessed up to 10 days ]
    Units: millimole/liter



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04358835


Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Mackenzie Cervenka, MD Johns Hopkins University
Additional Information:
Publications:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04358835    
Other Study ID Numbers: IRB00247383
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
ketogenic diet
Intensive care
COVID-19
Mechanical ventilation
Intubated patients
coronavirus