BVAC19: Blood Volume Assessment in COVID-19 and Bacterial Sepsis

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT04517695
Collaborator
Daxor Corporation (Industry)
40
1
41
1

Study Details

Study Description

Brief Summary

In patients with SARS-CoV-2 or bacterial 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 relationship of these parameters with parameters of cardiac performance, lung edema and sublingual microcirculatory perfusion parameters have never been studied.

Condition or Disease Intervention/Treatment Phase
  • Device: BVA-100
  • Device: Transpulmonary Thermodilution (TPTD)
  • Device: Sublingual Microcirculation

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. 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, the capillary leak and parameters of cardiac performance, lung edema and sublingual microcirculatory perfusion and their trajectory during the early phase of hospitalization of patients with SARS-CoV-2 or bacterial infection.

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Blood Volume, Components and Capillary Leak in ICU Patients With SARS-CoV-2 and Bacterial Infections
Actual Study Start Date :
Aug 1, 2020
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm 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.

Device: Transpulmonary Thermodilution (TPTD)
TPTD consists of placing a thermistor-equipped catheter in a central artery (usually the femoral or axillary artery) and injecting cold saline solution into a central vein through a central venous catheter.
Other Names:
  • PICCO
  • Device: Sublingual Microcirculation
    With incident dark field imaging, the CytoCam device can record digital image sequences using a handheld camera. In the current study the camera will be used to non-invasively record images of the sublingual microcirculation.
    Other Names:
  • CytoCam
  • ICU Patients with bacterial infection

    Patients who are admitted to the ICU with a confirmed bacterial infection. Bacterial infection is defined as the clinical suspicion of a bacterial infection with the presence of two or more clinical markers of infection: abnormal body temperature (>38C or <36C) increased heart rate (>90 b/min), increased respiratory rate > 20/min or a decreased arterial CO2: PaCO2 < 32 mmHg Abnormal white blood cell count: < 4000 mm3 or > 12,000 /mm3 or > 10% immature cells OR The presence of a positive (blood) culture with bacterial growth.

    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.

    Device: Transpulmonary Thermodilution (TPTD)
    TPTD consists of placing a thermistor-equipped catheter in a central artery (usually the femoral or axillary artery) and injecting cold saline solution into a central vein through a central venous catheter.
    Other Names:
  • PICCO
  • Device: Sublingual Microcirculation
    With incident dark field imaging, the CytoCam device can record digital image sequences using a handheld camera. In the current study the camera will be used to non-invasively record images of the sublingual microcirculation.
    Other Names:
  • CytoCam
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Absolute Total Blood Volume [Day 1, Day of ICU Discharge (up to day 21)]

      Absolute total blood volume calculated using BVA-100 software.

    2. Change in Total Blood Volume Relative to Ideal Body Weight [Day 1, Day of ICU Discharge (up to day 21)]

      Total blood volume relative to ideal body weight calculated using the BVA-100 software.

    3. Change in Absolute Red Blood Cell Volume [Day 1, Day of ICU Discharge (up to day 21)]

      Absolute red blood cell volume calculated using the BVA-100 software.

    4. Change in Red Blood Cell Volume Relative to Ideal Body Weight [Day 1, Day of ICU Discharge (up to day 21)]

      Red blood cell volume relative to ideal body weight calculated using the BVA-100 software.

    5. Change in Absolute Plasma Volume [Day 1, Day of ICU Discharge (up to day 21)]

      Absolute plasma volume calculated using the BVA-100 software.

    6. Change in Plasma Volume Relative to Ideal Body Weight [Day 1, Day of ICU Discharge (up to day 21)]

      Plasma volume relative to ideal body weight calculated using the BVA-100 software.

    7. Change in Transudation Rate of Albumin [Day 1, Day of ICU Discharge (up to day 21)]

      Transudation rate of albumin calculated using the BVA-100 software. An increase indicates the transudation rate increased during the observational period.

    8. Change in Heart Rate [Day 1, Day of ICU Discharge (up to day 21)]

      Measured using PICCO. Heart rate expressed as beats per minute (BPM).

    9. Change in Cardiac Output [Day 1, Day of ICU Discharge (up to day 21)]

      Measured using PICCO. Cardiac output expressed in liters per minute (L/min).

    10. Change in Stroke Volume [Day 1, Day of ICU Discharge (up to day 21)]

      Measured using PICCO. Stroke volume expressed in milliliters per square meter (mL/m2).

    11. Change in Systemic Vascular Resistance (SVR) [Day 1, Day of ICU Discharge (up to day 21)]

      Measured using PICCO. SVR expressed in dynes/second/cm^5.

    12. Change in Global End Diastolic Volume (GEDV) Index [Day 1, Day of ICU Discharge (up to day 21)]

      Measured using PICCO. GEDV expressed in mL/m2.

    13. Change in Intra-Thoracic Blood Volume Index (ITBVI) [Day 1, Day of ICU Discharge (up to day 21)]

      Measured using PICCO. ITBVI expressed in mL/m2.

    14. Change in Extravascular Lung Water (EVLW) [Day 1, Day of ICU Discharge (up to day 21)]

      Measured using PICCO. EVLW expressed in mL/kg.

    15. Maximum Stroke Volume [Up to Day of ICU Discharge (up to day 21)]

      Measured using PICCO. Stroke volume expressed in mL/m2.

    16. Minimum Stroke Volume [Up to Day of ICU Discharge (up to day 21)]

      Measured using PICCO. Stroke volume expressed in mL/m2.

    17. Maximum Pulse Pressure [Up to Day of ICU Discharge (up to day 21)]

      Measured using PICCO. Pulse pressure expressed in millimeters of mercury (mmHg).

    18. Minimum Pulse Pressure [Up to Day of ICU Discharge (up to day 21)]

      Measured using PICCO. Pulse pressure expressed in millimeters of mercury (mmHg).

    19. Change in Systolic Blood Pressure [Day 1, Day of ICU Discharge (up to day 21)]

      Measured using PICCO. Systolic blood pressure expressed in mmHg.

    20. Change in Diastolic Blood Pressure [Day 1, Day of ICU Discharge (up to day 21)]

      Measured using PICCO. Diastolic blood pressure expressed in mmHg.

    21. Mean Blood Pressure [Up to Day of ICU Discharge (up to day 21)]

      Measured using PICCO. Blood pressure expressed in mmHg.

    22. Change in Central Venous Pressure (CVP) [Day 1, Day of ICU Discharge (up to day 21)]

      Measured using PICCO. CVP expressed in mmHg.

    Secondary Outcome Measures

    1. Number of Participants with New Onset Renal Injury [Up to Day of ICU Discharge (up to day 21)]

    2. Number of Participants Requiring Renal Replacement Therapy [Up to Day of ICU Discharge (up to day 21)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Confirmed SARS-CoV-2 or bacterial 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

    • Arterial catheter considered indicated by primary team caring for the patient

    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

    • Patients with chronic renal failure requiring renal replacement therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NYU Langone Health New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health
    • Daxor Corporation

    Investigators

    • Principal Investigator: Jan Bakker, MD, PhD, NYU Langone Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT04517695
    Other Study ID Numbers:
    • 20-00896
    First Posted:
    Aug 18, 2020
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 18, 2022