WithdrawnNot Applicable

Noninvasive Monitor of Vascular Volume Fluid Shifts

Stopped: Sponsor decided to close the study.

United States0Started 2021-12-15

Plain-language summary

Blood volume measurements are a critical step in the emergency care of trauma patients. The typical approach to this is to rely on historical information, physical examination and metrics such as heart rate. There is currently no good real-time measure to track blood volume. This study investigates the use of phonocardiography (listening to the sounds made by the heart) to track changes in central blood volume.

Who can participate

Age range

18 Years – 49 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.

Lower Body Negative Pressure (LBNP) participants: Inclusion Criteria: * In generally good health * Free of systemic diseases * No contraindications to LBNP exposure. * No prior history of cardiovascular disease * Normal resting systolic blood pressure (SBP, 100-140 mm Hg) and diastolic blood pressure (DBP, 60-90 mm Hg). Exclusion Criteria: * Individuals who, after lying supine for five minutes, show a greater than 10 mm Hg drop in systolic pressure or a greater than 20 beats/minute increase in heart rate with standing during pre-enrollment evaluation Blood draw participants: Inclusion Criteria: * In generally good health * Free of systemic diseases * No current or prior history of cardiovascular disease or cardiovascular reactive drugs * Blood donors through the DHMC blood donation center * Healthy volunteers * People who are taking part in another study where about 500 ml of blood is being drawn * Therapeutic phlebotomy patients (hemochromatosis or polycythemia vera patients) Exclusion Criteria: * Pregnancy

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 cardiac cycle time intervals

Timeframe: Through study completion; 3 hours

Change in phonographic characteristics - amplitude

Timeframe: Through study completion; 3 hours

Change in phonographic characteristics - frequency

Timeframe: Through study completion; 3 hours

Trial details

NCT IDNCT05080881

SponsorDartmouth-Hitchcock Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-01

View on ClinicalTrials.gov More Blood Loss trials

Plain-language summary

Who can participate

Age range

18 Years – 49 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.