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

N/A

Waitlist Available

Led By Jan Bakker, MD, PhD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, day of icu discharge (up to day 21)

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Sepsis
Bacterial Infection
Moist Dressings Over Meshed Autografts
Coronavirus
Acute Respiratory Distress Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day of icu discharge (up to day 21)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day of icu discharge (up to day 21)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day of icu discharge (up to day 21) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Absolute Plasma Volume

Change in Absolute Red Blood Cell Volume

Change in Absolute Total Blood Volume

+19 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sublingual Microcirculation

2020

N/A

~40

BVA-100

2020