Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department
ConditionFluid Therapy
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Monastir
About this trial
Intravascular volume expansion is a common intervention in critically ill patients with acute circulatory failure.we test the hypothesis that a mini-bolus fluid challenge, of either 50 ml , can predict fluid responsiveness in spontaneously breathing patients with hemodynamic instability.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with spontaneous breathing
urine output of below 0.5ml/kg per hour over 1 hour
tachycardia (heart rate of greater than 100 beats per minute)
mottled skin.
Disqualifiers
Cardiac arrest
Acute respiratory distress syndrome
Coma Glasgow Scale < 14
Age of less than 18 years
Trial design
Design model
Parallel
Treatments tested in this trial
Mini bolus 50
Combination productreceiving a "mini-bolus A":50 ml of crystalloid solution, regularly infused over 30 seconds
passive leg rising test
Diagnostic testPassive leg raising technique: Initially, the patient is placed semi-recumbent with the head of the bed at 45°. After recording baseline measurement, the head of the bed is lowered and the legs are elevated to 45° for 2 minutes
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Mini Bolus 50Active comparator 1 intervention
Group B: PLROther 1 intervention
Trial outcomes
Primary outcomes
1
Measurement of the cardiac flow with the Estimate Continuous CO escco and SVescco (EsCCO) to predict the fluid responsiveness .
Predicting fluid responsiveness in spontaneously breathing patients with hemodynamic instability.
Time frame
at 3 minutes following fluid load in the day of admissionSponsors and contacts
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Source ClinicalTrials.gov