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Blood Volume Assessment in COVID-19 ICU Patients - BVAC19

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ClinicalTrials.gov Identifier: NCT04517695
Recruitment Status : Recruiting
First Posted : August 18, 2020
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:

In patients with SARS-CoV-2 infection admitted to the intensive care unit (ICU), the state of the intravascular volume, the characteristics of the blood volume components, and the development of a vascular leak is currently unknown.

The primary objective is to describe the blood volume, the volume of blood components, and the capillary leak and their trajectory during the early phase of hospitalization of patients with SARS-CoV-2 infection.


Condition or disease Intervention/treatment
Covid19 Acute Respiratory Distress Syndrome Device: BVA-100

Detailed Description:

Acute respiratory failure related to infection by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), is the main reason for ICU admission in in the majority of patients admitted to the ICU in this viral syndrome, and it presents a significant clinical challenge. Severe hypoxemia in these patients is thought to be related in part to generation of alveolar edema. This would be related to the specific infection related injury of the alveoli-capillary membrane, however other factors could be related to edema formation. Although patients meet criteria for the Acute Respiratory Distress Syndrome (ARDS), there is significant controversy about whether the lungs of the COVID-19 patients have the characteristics of ARDS and thus whether the treatment should mimic treatment of ARDS due to other causes. A general principle in ARDS patients is to avoid positive fluid balances as this may contribute to alveolar edema. Also, the guidelines on the management of COVID-19 patients by the Society of Critical Care Medicine advocate a conservative fluid strategy [8]. However, uncorrected hypovolemia may result in additional organ dysfunction (especially kidney injury). The clinical fluid status is usually estimated by the presence of peripheral edema and daily fluid balances and thus prone to errors as these are poorly related to the circulating blood volume. Management of patients with sepsis based on blood volume measurements and red blood cell volume, to disclose true anemia, has been shown to improve outcome. Finally, the transudation of albumin in the extravascular space has been shown to be associated with outcome of critically ill patients. It is highly plausible that these parameters could help guide the care of COVID-19 patients given the available data in the literature, thus promoting better treatment of these patients.

This is a prospective multicenter study where the treatment team is blinded to the results of the study. The primary objective of the study is to describe the blood volume, the volume of blood components, and the capillary leak and their trajectory during the early phase of hospitalization of patients with SARS-CoV-2 infection.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Blood Volume, Components and Capillary Leak in SARS-CoV-2 Infections
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021


Group/Cohort Intervention/treatment
COVID-19 ICU Patients
Patients who are admitted to the ICU with a confirmed SARS-CoV-2 infection
Device: BVA-100
The BVA-100 is a software package designed to calculate human blood volume using the method of tracer dilution. It uses tagged serum albumin (a commonly used tag is 131I, resulting in "131I -HSA"). Data inputs to the software come from the measured characteristics of subject blood samples (hematocrit and tracer concentration) and tracer calibration standards. The package also calculates the subject expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, associated red blood cell volumes, and transudation rate are reported, with statistics showing the quality of the results. The subject blood samples and calibration standards are measured in a gamma counter, whose output is automatically, or manually, input to this calculation program.




Primary Outcome Measures :
  1. Total blood volume (absolute and relative to ideal body weight) [ Time Frame: Day 1 ]
    Reported by the BVA-100 software

  2. Total blood volume (absolute and relative to ideal body weight) [ Time Frame: Day 2 ]
    Reported by the BVA-100 software

  3. Total blood volume (absolute and relative to ideal body weight) [ Time Frame: Day 3 ]
    Reported by the BVA-100 software

  4. Total blood volume (absolute and relative to ideal body weight) [ Time Frame: Day 7 ]
    Reported by the BVA-100 software

  5. Total blood volume (absolute and relative to ideal body weight) [ Time Frame: Day 10 ]
    Reported by the BVA-100 software

  6. Total blood volume (absolute and relative to ideal body weight) [ Time Frame: Day 14 ]
    Reported by the BVA-100 software

  7. Total blood volume (absolute and relative to ideal body weight) [ Time Frame: Day of ICU Discharge, up to day 21 ]
    Reported by the BVA-100 software

  8. Red blood cell volume (absolute and relative to ideal body weight) [ Time Frame: Day 1 ]
    Reported by the BVA-100 software

  9. Red blood cell volume (absolute and relative to ideal body weight) [ Time Frame: Day 2 ]
    Reported by the BVA-100 software

  10. Red blood cell volume (absolute and relative to ideal body weight) [ Time Frame: Day 3 ]
    Reported by the BVA-100 software

  11. Red blood cell volume (absolute and relative to ideal body weight) [ Time Frame: Day 7 ]
    Reported by the BVA-100 software

  12. Red blood cell volume (absolute and relative to ideal body weight) [ Time Frame: Day 10 ]
    Reported by the BVA-100 software

  13. Red blood cell volume (absolute and relative to ideal body weight) [ Time Frame: Day 14 ]
    Reported by the BVA-100 software

  14. Red blood cell volume (absolute and relative to ideal body weight) [ Time Frame: Day of ICU Discharge, up to day 21 ]
    Reported by the BVA-100 software

  15. Plasma volume (absolute and relative to ideal body weight) [ Time Frame: Day 1 ]
    Reported by the BVA-100 software

  16. Plasma volume (absolute and relative to ideal body weight) [ Time Frame: Day 2 ]
    Reported by the BVA-100 software

  17. Plasma volume (absolute and relative to ideal body weight) [ Time Frame: Day 3 ]
    Reported by the BVA-100 software

  18. Plasma volume (absolute and relative to ideal body weight) [ Time Frame: Day 7 ]
    Reported by the BVA-100 software

  19. Plasma volume (absolute and relative to ideal body weight) [ Time Frame: Day 10 ]
    Reported by the BVA-100 software

  20. Plasma volume (absolute and relative to ideal body weight) [ Time Frame: Day 14 ]
    Reported by the BVA-100 software

  21. Plasma volume (absolute and relative to ideal body weight) [ Time Frame: Day of ICU Discharge, up to day 21 ]
    Reported by the BVA-100 software

  22. Transudation rate of the 131I albumin tracer [ Time Frame: Day 1 ]
    Reported by the BVA-100 software

  23. Transudation rate of the 131I albumin tracer [ Time Frame: Day 2 ]
    Reported by the BVA-100 software

  24. Transudation rate of the 131I albumin tracer [ Time Frame: Day 3 ]
    Reported by the BVA-100 software

  25. Transudation rate of the 131I albumin tracer [ Time Frame: Day 7 ]
    Reported by the BVA-100 software

  26. Transudation rate of the 131I albumin tracer [ Time Frame: Day 10 ]
    Reported by the BVA-100 software

  27. Transudation rate of the 131I albumin tracer [ Time Frame: Day 14 ]
    Reported by the BVA-100 software

  28. Transudation rate of the 131I albumin tracer [ Time Frame: Day of ICU Discharge, up to day 21 ]
    Reported by the BVA-100 software


Secondary Outcome Measures :
  1. Incidence of new onset renal injury (failure) and requirement for renal replacement therapy [ Time Frame: Up to Day 14 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the ICU with a confirmed SARS-CoV-2 infection
Criteria

Inclusion Criteria:

  • Confirmed SARS-CoV-2 infection
  • Patient admitted to the ICU
  • Patient age is between 18 and 95 years
  • Patent peripheral or central venous line from which blood draws can be made and through which the 131I bolus can be administered

Exclusion Criteria:

  • Refused informed consent to participate in the study
  • Pregnant or possible pregnant women
  • Patient unlikely to survive more than 72h
  • Patient with life sustaining treatment limitations (use of renal replacement therapy)
  • Patient already on or likely to be placed on extra-corporeal membrane oxygenation support within 48h after admission
  • Known allergy to iodine or iodinated 131I albumin
  • Confirmed or suspected bacterial or another virus infection on admission
  • Patients with chronic renal failure requiring renal replacement therapy

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): NCT04517695


Contacts
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Contact: Jan Bakker, MD, PhD 718-630-7000 Jan.Bakker@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Jan Bakker, MD, PhD       Jan.Bakker@nyulangone.org   
Principal Investigator: Jan Bakker, MD, PhD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Jan Bakker, MD, PhD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04517695    
Other Study ID Numbers: 20-00896
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury