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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-90
SponsorCentraCare

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

Screening criteria: 1. New onset of hypotension: MAP \< 65 mm HG for \> 5 min 2. Escalation in Nor-epinephrine needs\> 0.03 ug/kg/min 3. High MAP goal Low Urine output \< 0.5ml/kg/hr for \> 2 hours Elevated Lactate \> 4 moles/L Decreased Lactate clearance (\< 40%) 4. Bedside Echo Inc. VTI No obvious Hypovolemia No Low EF or No Pericardial effusion

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Passive leg raise, SVI via bioreactance, Echo based VTI

    Diagnostic test

    No interventions other than fluid challenge

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Fluid responder1 intervention
Group B: Fluid non responder0 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
3 hours after the initial passive leg raise

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.