An observational study in Covid19, Acute Respiratory Distress Syndrome and Bacterial Sepsis, sponsored by NYU Langone Health. Completed at 3 sites in United States. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2023-09-21.
Sponsored by NYU Langone Health · Observational
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 39 is below the median of 240 across 2,136 observational studies indexed under Infections.
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Patients admitted to the ICU with a confirmed SARS-CoV-2 infection or bacterial infection
Exclusion Criteria:
Patients who are admitted to the ICU with a confirmed SARS-CoV-2 infection
Device: BVA-100 · Device: Transpulmonary Thermodilution (TPTD) · Device: Sublingual Microcirculation
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
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.
Also known as: PICCO
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
Change in Absolute Total Blood Volume
Absolute total blood volume calculated using BVA-100 software.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1, Day of ICU Discharge (up to day 21)
Change in Absolute Plasma Volume
Absolute plasma volume calculated using the BVA-100 software.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1, Day of ICU Discharge (up to day 21)
Change in Extravascular Lung Water (EVLW)
Measured using PICCO. EVLW expressed in mL/kg.
Time frame: Day 1, Day of ICU Discharge (up to day 21)
Maximum Stroke Volume
Measured using PICCO. Stroke volume expressed in mL/m2.
Time frame: Up to Day of ICU Discharge (up to day 21)
Minimum Stroke Volume
Measured using PICCO. Stroke volume expressed in mL/m2.
Time frame: Up to Day of ICU Discharge (up to day 21)
Maximum Pulse Pressure
Measured using PICCO. Pulse pressure expressed in millimeters of mercury (mmHg).
Time frame: Up to Day of ICU Discharge (up to day 21)
Minimum Pulse Pressure
Measured using PICCO. Pulse pressure expressed in millimeters of mercury (mmHg).
Time frame: Up to Day of ICU Discharge (up to day 21)
Change in Systolic Blood Pressure
Measured using PICCO. Systolic blood pressure expressed in mmHg.
Time frame: Day 1, Day of ICU Discharge (up to day 21)
Change in Diastolic Blood Pressure
Measured using PICCO. Diastolic blood pressure expressed in mmHg.
Time frame: Day 1, Day of ICU Discharge (up to day 21)
Mean Blood Pressure
Measured using PICCO. Blood pressure expressed in mmHg.
Time frame: Up to Day of ICU Discharge (up to day 21)
Change in Central Venous Pressure (CVP)
Measured using PICCO. CVP expressed in mmHg.
Time frame: Day 1, Day of ICU Discharge (up to day 21)
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)
Plan to share: No
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