Blood Volume Assessment in COVID-19 and Bacterial Sepsis
(BVAC19 Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byJan Bakker, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

Confirmed SARS-CoV-2 or bacterial infection

Patient admitted to the ICU

Patient age is between 18 and 95 years

See 2 more

Treatment Details

Interventions

BVA-100 (Diagnostic Device)
Sublingual Microcirculation (Diagnostic Device)
TPTD (Diagnostic Device)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: ICU Patients with bacterial infectionExperimental Treatment3 Interventions

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.

Group II: COVID-19 ICU PatientsExperimental Treatment3 Interventions

Patients who are admitted to the ICU with a confirmed SARS-CoV-2 infection