NCT06390423 · CentraCare
Passive Leg Raise and Mini-fluid Challenge Effect on Various Cardiac Output Surrogates for Fluid Responsiveness
(PHOENIX)
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Passive leg raise, SVI via bioreactance, Echo based VTI
No interventions other than fluid challenge
Primary outcome measures
Vasopressor dose in Nor-epinephrine equivalents (NE) measured as mcg/kg/min
Time frame: 3 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Saint Cloud, Minnesota
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Data: ClinicalTrials.gov · synced Aug 22, 2024 · Source of record for eligibility and locations