Blood Volume Assessment in COVID-19 and Bacterial Sepsis

NCT04517695 | Completed FDA Device

• 1 other identifier: 20-00896
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Covid19; Acute Respiratory Distress Syndrome; Bacterial Sepsis; Bacterial Infections

Outcome Measures

Primary Outcomes (22)

• Change in Absolute Total Blood Volume

  Absolute total blood volume calculated using BVA-100 software.

  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.

  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.

  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.

  Day 1, Day of ICU Discharge (up to day 21)

• Change in Absolute Plasma Volume

  Absolute plasma volume calculated using the BVA-100 software.

  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.

  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.

  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).

  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).

  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).

  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.

  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.

  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.

  Day 1, Day of ICU Discharge (up to day 21)

• Change in Extravascular Lung Water (EVLW)

  Measured using PICCO. EVLW expressed in mL/kg.

  Day 1, Day of ICU Discharge (up to day 21)

• Maximum Stroke Volume

  Measured using PICCO. Stroke volume expressed in mL/m2.

  Up to Day of ICU Discharge (up to day 21)

• Minimum Stroke Volume

  Measured using PICCO. Stroke volume expressed in mL/m2.

  Up to Day of ICU Discharge (up to day 21)

• Maximum Pulse Pressure

  Measured using PICCO. Pulse pressure expressed in millimeters of mercury (mmHg).

  Up to Day of ICU Discharge (up to day 21)

• Minimum Pulse Pressure

  Measured using PICCO. Pulse pressure expressed in millimeters of mercury (mmHg).

  Up to Day of ICU Discharge (up to day 21)

• Change in Systolic Blood Pressure

  Measured using PICCO. Systolic blood pressure expressed in mmHg.

  Day 1, Day of ICU Discharge (up to day 21)

• Change in Diastolic Blood Pressure

  Measured using PICCO. Diastolic blood pressure expressed in mmHg.

  Day 1, Day of ICU Discharge (up to day 21)

• Mean Blood Pressure

  Measured using PICCO. Blood pressure expressed in mmHg.

  Up to Day of ICU Discharge (up to day 21)

• Change in Central Venous Pressure (CVP)

  Measured using PICCO. CVP expressed in mmHg.

  Day 1, Day of ICU Discharge (up to day 21)

Secondary Outcomes (2)

• Number of Participants with New Onset Renal Injury

  Up to Day of ICU Discharge (up to day 21)

• Number of Participants Requiring Renal Replacement Therapy

  Up to Day of ICU Discharge (up to day 21)

Study Arms (2)

COVID-19 ICU Patients

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

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.

Device: BVA-100; Device: Transpulmonary Thermodilution (TPTD); Device: Sublingual Microcirculation

Interventions

BVA-100 DEVICE

The BVA-100 is a software package designed to calculate human blood volume using the method of tracer dilution. It uses tagged serum albumin.

COVID-19 ICU Patients; ICU Patients with bacterial infection

Transpulmonary Thermodilution (TPTD) DEVICE

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.

Also known as: PICCO

COVID-19 ICU Patients; ICU Patients with bacterial infection

Sublingual Microcirculation DEVICE

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.

Also known as: CytoCam

COVID-19 ICU Patients; ICU Patients with bacterial infection

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the ICU with a confirmed SARS-CoV-2 infection or bacterial infection

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Daxor Corporation: collaborator

Study Sites (3)

Uniformed Services University of the Health Sciences

Bethesda, Maryland, 20814, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome; Bacterial Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Bacterial Infections and Mycoses

Study Officials

• Jan Bakker, MD, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 18, 2020
• Study Start: August 1, 2020
• Primary Completion: April 9, 2023
• Study Completion: April 9, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)