Assessing fluid responsiveness in critically ill patients using passive leg raise and mini-fluid challenge
Passive Leg Raise and Mini-fluid Challenge Effect on Various Cardiac Output Surrogates Such as Pulse Pressure Variation (PPV), End-tidal CO2 (Carbon Dioxide), Bioreactance (Stroke Volume Index -SVI) and Velocity Time Integral on Echocardiographic Exam for Fluid Responsiveness in Patients With Moderately Severe ARDS (Acute Respiratory Distress Syndrome)
This study is testing two methods to see if critically ill patients with ARDS need extra fluids to help their hearts work better without giving them too much fluid.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 64 (estimated) |
| Ages | 30 Years to 90 Years |
| Sex | All |
| Sponsor | CentraCare Academic / other |
| Locations | 1 site (Saint Cloud, Minnesota) |
| Trial ID | NCT06390423 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of different techniques for assessing fluid responsiveness in critically ill patients with moderate to severe ARDS. It compares the passive leg raise and mini-fluid challenge methods to measure changes in various cardiac output surrogates, including pulse pressure variation and stroke volume index. The study aims to identify patients who would benefit from fluid administration while minimizing the risks associated with unnecessary fluid overload. Hemodynamic assessments will be performed using bedside echocardiography and monitoring systems.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 30 to 90 years diagnosed with vasodilatory shock and ARDS, who are mechanically ventilated and under sedation.
Not a fit: Patients with arrhythmias, structural heart disease, or those on extracorporeal support are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of fluid therapy in critically ill patients, potentially reducing mortality and complications associated with inappropriate fluid administration.
How similar studies have performed: Other studies have shown promise in using dynamic assessments for fluid responsiveness, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Saint Cloud, Minnesota
- St Cloud Hospital — Saint Cloud, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Ramakanth Pata, MD FCCP — Centracare health System
- Study coordinator: Ramakanth Pata
- Email: cookybrey1@gmail.com
- Phone: 320-240-2207
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.