CompletedNot Applicable

Blood Volume Assessment in COVID-19 and Bacterial Sepsis

United States39 participantsStarted 2020-08-01

Plain-language 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.

Who can participate

Age range

18 Years – 95 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Absolute Total Blood Volume

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

Change in Total Blood Volume Relative to Ideal Body Weight

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

Change in Absolute Red Blood Cell Volume

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

Change in Red Blood Cell Volume Relative to Ideal Body Weight

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

Change in Absolute Plasma Volume

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

Change in Plasma Volume Relative to Ideal Body Weight

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

Change in Transudation Rate of Albumin

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

Trial details

NCT IDNCT04517695

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-04-09

View on ClinicalTrials.gov More Covid19 trials

Plain-language summary

Who can participate

Age range

18 Years – 95 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Absolute Total Blood Volume

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

Change in Total Blood Volume Relative to Ideal Body Weight

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

Change in Absolute Red Blood Cell Volume

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

Change in Red Blood Cell Volume Relative to Ideal Body Weight

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

Change in Absolute Plasma Volume

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

Change in Plasma Volume Relative to Ideal Body Weight

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

Change in Transudation Rate of Albumin

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