Skip to main content
OpenTrials
Completed

NCT Number: NCT04517695

Blood Volume Assessment in COVID-19 and Bacterial Sepsis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uniformed Services University of the Health Sciences, Bethesda, Maryland, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

BVA-100

Device

The BVA-100 is a software package designed to calculate human blood volume using the method of tracer dilution. It uses tagged serum albumin.

Transpulmonary Thermodilution (TPTD)

Device

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

Sublingual Microcirculation

Device

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

Primary outcomes

  1. Change in Absolute Total Blood Volume

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: Day 1, Day of ICU Discharge (up to day 21)

    Measured using PICCO. EVLW expressed in mL/kg.

  15. Maximum Stroke Volume

    Time frame: Up to Day of ICU Discharge (up to day 21)

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

  16. Minimum Stroke Volume

    Time frame: Up to Day of ICU Discharge (up to day 21)

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

  17. Maximum Pulse Pressure

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Day 1, Day of ICU Discharge (up to day 21)

    Measured using PICCO. Diastolic blood pressure expressed in mmHg.

  21. Mean Blood Pressure

    Time frame: 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)

    Time frame: Day 1, Day of ICU Discharge (up to day 21)

    Measured using PICCO. CVP expressed in mmHg.

Secondary outcomes

  1. Number of Participants with New Onset Renal Injury

    Time frame: Up to Day of ICU Discharge (up to day 21)

  2. Number of Participants Requiring Renal Replacement Therapy

    Time frame: Up to Day of ICU Discharge (up to day 21)

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Daxor Corporation

Registry information

Official study title

Blood Volume, Components and Capillary Leak in ICU Patients With SARS-CoV-2 and Bacterial Infections

Acronym: BVAC19

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 18, 2020
Registry last updated
Sep 21, 2023

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.