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Observational Study on Fluid Responsiveness in Critically Ill Patients

This study is looking at different ways to tell if critically ill patients, especially those with severe breathing problems (ARDS) and low blood pressure (vasodilatory shock), would benefit from receiving more fluids. Giving too much or too little fluid can be harmful, so doctors need to know who will respond well to fluids. Researchers are comparing techniques like the passive leg raise (lifting a patient's legs to see how their body responds) and a mini-fluid challenge (giving a small amount of fluid) to see how they affect various heart measurements. These measurements include stroke volume index (SVI), which is how much blood your heart pumps with each beat, and velocity time integral (VTI), which also measures blood flow. The study aims to enroll 64 participants aged 30-90 who are deeply sedated and on a ventilator. The main goal is to see how these measurements relate to the dose of blood pressure medication (norepinephrine) needed 3 hours after the passive leg raise.

Study design
This is an observational study, meaning researchers will watch and record information without giving new treatments. It plans to include 64 participants.
What's involved
You would have your heart measurements taken before and after a passive leg raise, and after being repositioned. Your breathing machine settings would be temporarily adjusted for measurements.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured 3 hours after the initial passive leg raise.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06390423

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

UNKNOWN
Not specifiedAges 30–90Observational
CentraCare
~64 participants
Updated 2024-08-22 on ClinicalTrials.gov
What's tested:Passive leg raise, SVI via bioreactance, Echo based VTI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Vasopressor dose in Nor-epinephrine equivalents (NE) measured as mcg/kg/min
Measured over 3 hours after the initial passive leg raise

Conditions

Fluid Responsiveness

Explore related trials

Respiratory Distress Syndrome, AcuteVasodilatory Shock

NCT06390423

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • St Cloud Hospital

    Saint Cloud, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ramakanth Pata, MD FCCP · PRINCIPAL_INVESTIGATOR · Centracare health System

Who to contact

Ramakanth Pata
[email protected]
320-240-2207
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Vasopressor dose in Nor-epinephrine equivalents (NE) measured as mcg/kg/min3 hours after the initial passive leg raise

    We shall assess the need for vasopressor dose e.g nor-epinephrine dose. If the dose remains constant after fluid bolus until 3 hours, we shall consider them fluid resposive. If the dose requirement goes up despite fluid bolus, we shall label them fluid un-responsive