Covid19BVAC19NCT04517695
Blood Volume Assessment in COVID-19 and Bacterial Sepsis
An observational study of Covid19 and Acute Respiratory Distress Syndrome, run by NYU Langone Health at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Covid19, Acute Respiratory Distress Syndrome, Bacterial Sepsis
- What is being tested?
- BVA-100, Transpulmonary Thermodilution (TPTD) and Sublingual Microcirculation
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2020to 9 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the ICU with a confirmed SARS-CoV-2 infection or bacterial infection
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Uniformed Services University of the Health Sciences
Bethesda, Maryland, 20814
NYU Langone Health
New York, New York, 10016
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: Blood Volume, Components and Capillary Leak in ICU Patients With SARS-CoV-2 and Bacterial Infections
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.
Read the 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.
- Being tested
- BVA-100, Transpulmonary Thermodilution (TPTD), Sublingual Microcirculation
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BVA-100Device
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
Also called PICCO
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.
Sublingual MicrocirculationDevice
Also called CytoCam
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.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 ICU Patients | Patients who are admitted to the ICU with a confirmed SARS-CoV-2 infection Receives: Device: BVA-100; Device: Transpulmonary Thermodilution (TPTD); Device: Sublingual Microcirculation | |
| ICU Patients with bacterial infection | 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. Receives: Device: BVA-100; Device: Transpulmonary Thermodilution (TPTD); Device: Sublingual Microcirculation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Absolute Total Blood Volume
Absolute total blood volume calculated using BVA-100 software.
Measured: Day 1, Day of ICU Discharge (up to day 21)
Change in Total Blood Volume Relative to Ideal Body Weight
Total blood volume relative to ideal body weight calculated using the BVA-100 software.
Measured: Day 1, Day of ICU Discharge (up to day 21)
Change in Absolute Red Blood Cell Volume
Absolute red blood cell volume calculated using the BVA-100 software.
Measured: Day 1, Day of ICU Discharge (up to day 21)
Change in Red Blood Cell Volume Relative to Ideal Body Weight
Red blood cell volume relative to ideal body weight calculated using the BVA-100 software.
Measured: Day 1, Day of ICU Discharge (up to day 21)
Change in Absolute Plasma Volume
Absolute plasma volume calculated using the BVA-100 software.
Measured: Day 1, Day of ICU Discharge (up to day 21)
Change in Plasma Volume Relative to Ideal Body Weight
Plasma volume relative to ideal body weight calculated using the BVA-100 software.
Measured: Day 1, Day of ICU Discharge (up to day 21)
Change in Transudation Rate of Albumin
Transudation rate of albumin calculated using the BVA-100 software. An increase indicates the transudation rate increased during the observational period.
Measured: Day 1, Day of ICU Discharge (up to day 21)
Change in Heart Rate
Measured using PICCO. Heart rate expressed as beats per minute (BPM).
Measured: Day 1, Day of ICU Discharge (up to day 21)
Change in Cardiac Output
Measured using PICCO. Cardiac output expressed in liters per minute (L/min).
Measured: Day 1, Day of ICU Discharge (up to day 21)
Change in Stroke Volume
Measured using PICCO. Stroke volume expressed in milliliters per square meter (mL/m2).
Measured: Day 1, Day of ICU Discharge (up to day 21)
Change in Systemic Vascular Resistance (SVR)
Measured using PICCO. SVR expressed in dynes/second/cm^5.
Measured: Day 1, Day of ICU Discharge (up to day 21)
Change in Global End Diastolic Volume (GEDV) Index
Measured using PICCO. GEDV expressed in mL/m2.
Measured: Day 1, Day of ICU Discharge (up to day 21)
Change in Intra-Thoracic Blood Volume Index (ITBVI)
Measured using PICCO. ITBVI expressed in mL/m2.
Measured: Day 1, Day of ICU Discharge (up to day 21)
Change in Extravascular Lung Water (EVLW)
Measured using PICCO. EVLW expressed in mL/kg.
Measured: Day 1, Day of ICU Discharge (up to day 21)
Maximum Stroke Volume
Measured using PICCO. Stroke volume expressed in mL/m2.
Measured: Up to Day of ICU Discharge (up to day 21)
Minimum Stroke Volume
Measured using PICCO. Stroke volume expressed in mL/m2.
Measured: Up to Day of ICU Discharge (up to day 21)
Maximum Pulse Pressure
Measured using PICCO. Pulse pressure expressed in millimeters of mercury (mmHg).
Measured: Up to Day of ICU Discharge (up to day 21)
Minimum Pulse Pressure
Measured using PICCO. Pulse pressure expressed in millimeters of mercury (mmHg).
Measured: Up to Day of ICU Discharge (up to day 21)
Change in Systolic Blood Pressure
Measured using PICCO. Systolic blood pressure expressed in mmHg.
Measured: Day 1, Day of ICU Discharge (up to day 21)
Change in Diastolic Blood Pressure
Measured using PICCO. Diastolic blood pressure expressed in mmHg.
Measured: Day 1, Day of ICU Discharge (up to day 21)
Mean Blood Pressure
Measured using PICCO. Blood pressure expressed in mmHg.
Measured: Up to Day of ICU Discharge (up to day 21)
Change in Central Venous Pressure (CVP)
Measured using PICCO. CVP expressed in mmHg.
Measured: Day 1, Day of ICU Discharge (up to day 21)
Secondary outcomes (2)
Number of Participants with New Onset Renal Injury
Measured: Up to Day of ICU Discharge (up to day 21)
Number of Participants Requiring Renal Replacement Therapy
Measured: Up to Day of ICU Discharge (up to day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start1 Aug 2020
- Primary completion9 Apr 2023
- Study completion9 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Daxor Corporation
- Responsible party
- Sponsor
- Investigators
- Jan Bakker, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517695
- Sponsor's protocol ID
- 20-00896
- Acronym
- BVAC19
- Status last verified
- Sep 2023
- First submitted
- 14 Aug 2020
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Volume, Components and Capillary Leak in ICU Patients With SARS-CoV-2 and Bacterial Infections
- ClinicalTrials.gov ID
- NCT04517695
- Acronym / sponsor ID
- BVAC19 / 20-00896
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Daxor Corporation
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 9 Apr 2023 (actual)
- Study completion
- 9 Apr 2023 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 ICU Patients | – | Device: BVA-100, Device: Transpulmonary Thermodilution (TPTD), Device: Sublingual MicrocirculationPatients who are admitted to the ICU with a confirmed SARS-CoV-2 infection |
| ICU Patients with bacterial infection | – | Device: BVA-100, Device: Transpulmonary Thermodilution (TPTD), Device: Sublingual MicrocirculationPatients 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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU with a confirmed SARS-CoV-2 infection or bacterial infection
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BVA-100The BVA-100 is a software package designed to calculate human blood volume using the method of tracer dilution. It uses tagged serum albumin. | Device | COVID-19 ICU Patients, ICU Patients with bacterial infection |
| Transpulmonary Thermodilution (TPTD)Also: PICCOTPTD 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. | Device | COVID-19 ICU Patients, ICU Patients with bacterial infection |
| Sublingual MicrocirculationAlso: CytoCamWith 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. | Device | COVID-19 ICU Patients, ICU Patients with bacterial infection |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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.
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.
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.
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.
Maximum Stroke Volume
Time frame: Up to Day of ICU Discharge (up to day 21)
Measured using PICCO. Stroke volume expressed in mL/m2.
Minimum Stroke Volume
Time frame: Up to Day of ICU Discharge (up to day 21)
Measured using PICCO. Stroke volume expressed in mL/m2.
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).
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).
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.
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.
Mean Blood Pressure
Time frame: Up to Day of ICU Discharge (up to day 21)
Measured using PICCO. Blood pressure expressed in mmHg.
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.
2 secondary outcomes
Number of Participants with New Onset Renal Injury
Time frame: Up to Day of ICU Discharge (up to day 21)
Number of Participants Requiring Renal Replacement Therapy
Time frame: Up to Day of ICU Discharge (up to day 21)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Bakker, MD, PhD principal investigator
NYU Langone Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Acute Respiratory Distress Syndrome, run by NYU Langone Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Absolute Total Blood Volume (time frame: Day 1, Day of ICU Discharge (up to day 21)). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.