Blood Volume Assessment in COVID-19 and Bacterial Sepsis
Condition: Covid19; Acute Respiratory Distress Syndrome; Bacterial Sepsis; Bacterial Infections
MeSH terms: Infections; COVID-19; Sepsis; Bacterial Infections; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Study type: Observational

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.
    

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.
    

Intervention name(s): BVA-100; Transpulmonary Thermodilution (TPTD); Sublingual Microcirculation
Intervention type(s): Device; Device; Device
Intervention description(s): The BVA-100 is a software package designed to calculate human blood volume using the method of tracer dilution. It uses tagged serum albumin.; 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.; 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 intervention name(s): PICCO; CytoCam
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to the ICU with a confirmed SARS-CoV-2 infection or bacterial infection