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.
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.
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 Name: 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 Name: CytoCam
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
Uniformed Services University of the Health Sciences
Bethesda, Maryland, United States
NYU Langone Health
New York, New York, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Jan Bakker, MD, PhD
718-630-7000
Jan.Bakker@nyulangone.org
Jan Bakker, MD, PhD, Principal Investigator
NYU Langone Health