RecruitingNot Applicable

Passive Leg Raise and Mini-fluid Challenge Effect on Various Cardiac Output Surrogates for Fluid Responsiveness

United States64 participantsStarted 2023-07-01

Plain-language summary

In the critically ill population, fluid administration in an unstable patient is perhaps the most common intervention that is performed. Uncorrected hypovolemia with inappropriate vasopressors lead to organ hypoperfusion where as overzealous fluid administration especially in ARDS (Adult respiratory distress syndrome) can increase mortality. It has been estimated that only 50% of hemodynamically unstable critically ill patients are volume responsive, hence dynamic assessment of preload responsiveness has been proposed to better identify those individuals who would benefit from fluid bolus.

Who can participate

Age range

30 Years – 90 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: * Age between 30 - 90 years * Diagnosis of Vasodilatory Shock with no other obvious cause of hypotension * Diagnosis of ARDS with PF ratio \< 150 , PEEP \> 8 * Patients who are under paralysis or deeply sedated, on a mechanical ventilator Exclusion Criteria: * Patients with arrhythmias including atrial fibrillation * Patients with chest tube, intra-abdominal hypertension or with its risk factors * Patients with structural heart disease including pulmonary hypertension (RVSP \> 45) and heart failure * Patients on extracorporeal support such as ECMO, CRRT or MCS. * Patients with COPD with a premorbid FEV1 \< 1.5 L * Severe atherosclerotic vascular disease

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

Vasopressor dose in Nor-epinephrine equivalents (NE) measured as mcg/kg/min

Timeframe: 3 hours after the initial passive leg raise

Trial details

NCT IDNCT06390423

SponsorCentraCare

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06

Contact for this trial

Ramakanth Pata

320-240-2207 cookybrey1@gmail.com

View on ClinicalTrials.gov More Fluid Responsiveness trials