Blood Volume Assessment in COVID-19 and Bacterial Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2023-04-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Covid19 Acute Respiratory Distress Syndrome Bacterial Sepsis Bacterial Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 ICU Patients

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

BVA-100

Intervention Type 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.

Transpulmonary Thermodilution (TPTD)

Intervention Type 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.

Sublingual Microcirculation

Intervention Type 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.

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.

BVA-100

Intervention Type 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.

Transpulmonary Thermodilution (TPTD)

Intervention Type 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.

Sublingual Microcirculation

Intervention Type 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.

Interventions

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BVA-100

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

Intervention Type DEVICE

Transpulmonary Thermodilution (TPTD)

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.

Intervention Type DEVICE

Sublingual Microcirculation

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.

Intervention Type DEVICE

Other Intervention Names

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PICCO CytoCam

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No