"Mini Fluid Challenge Assessment: a Comparison Among Three Hemodynamic Tools"
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHumanitas Clinical and Research Center
About this trial
The mini fluid challenge (mini\_FC) is a functional hemodynamic test which has been used in different clinical contexts to assess fluid responsiveness.
This test is performed by rapidly injecting a small aliquot of fluid (100 ml over 1 minute), which is followed by the infusion of the residual aliquot of fluid.
Since the threshold of the mini\_FC identified by the literature is rather small (5% of stroke volume (SV) increase after the 100 ml bolus to discriminate between responder and non-responder), it is crucial that the hemodynamic tool assessing this change could be reliable. Moreover, the SV changes with inspiratory/expiratory movements and the increase after the mini\_FC should also consider the physiological fluctuations of the SV.
In the literature this test has been performed by means of tolls with different least significant change of the SV. The least significant change (LSC) represents the smallest difference between successive measurements of SV that can be considered to be a real change and not attributable to chance.
The purpose of this study is to assess the agreement among MOSTCARE system (4.5\& of SV LSC described in the literature) and the echocardiography (about 10% of SV LSC described in the literature) with the PICCO system (about 1% of SV LSC described in the literature - considered the gold standard) in discriminating fluid responsiveness after a mini\_FC
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
SAP ≤ 90 mmHg (or a decrease > 50 mm Hg in hypertensive patients)
or a mean arterial pressure (MAP) ≤ 70 mmHg
or the use of vasopressors to maintain SAP >90 mmHg,
associated with skin mottling; tachycardia ≥100 beats/min; urinary flow ≤0.5 mL/kg for at least 2 hours; blood lactate level ≥4 mmol/L.
Disqualifiers
known severe myocardial or valvular dysfunction
cardiac arrhythmias
severe acute respiratory distress syndrome
on-going haemodialysis or continuous hemofiltration
Trial population
Adults critically ill patients with acute circulatory failure, who require volume expansion decided by the clinician in charge.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
mini_FC
Diagnostic test100 ml of Crystalloids infused over 1 minute - data recording and new baseline - FC 4 ml/kg in 10 minutes - data recording
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Intervention _mini_FC1 intervention
Trial outcomes
Primary outcomes
1
Agreement of allocation
Number of responders and non-responders identified by the MOSTCARE and the Echocardiography with respect to the PICCO system (considered as gold standard)
Time frame
immediately after the procedureSecondary outcomes
1
Least significant change of the stroke volume - PICCO
off-line analysis of the recorded stroke volume change before the test
Time frame
5 minutes before FC administration2
Least significant change of the stroke volume - MOSTCARE
off-line analysis of the recorded stroke volume change before the test
Time frame
5 minutes before FC administration3
Least significant change of the stroke volume - Echocardiography
off-line analysis of the recorded stroke volume change before the test
Time frame
5 minutes before FC administration4
ROC curve - PICCO
ROC curve analysis of stroke volume changes after mini fluid challenge infusion
Time frame
1 minute after mini fluid challenge infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: