None listed
Conditions
Brief summary
This is a multi centric study aiming to test the reliability of a novel algorithm including the analysis of baseline pulse pressure variation (PPV), cardicac cycle efficiecy (CCE) and the difference between systolic pressure and dicrotic pressure (SAP-Pdic). In a previous pilot trial we found that this dynamic approach could predict the outcome of a fluid challenge better than purely baseline assessment of PPV. This could spare inappropriate fluid administration in those patient who should not receive fluid despite hemodynamic instability. To test our hypothesis will be studied 2 groups of patients in ICU (septic and non septic patients). All the patients will receive fluid as part of standard care and all the hemodynamic variables will be recorded by means of MostCare system. The reliability of the model will be evaluated post hoc (after fluid administration), and compared to the PPV value before fluid administration.
Interventions
Fluid challenge consisting in 500 ml of intravenous crystalloids (both saline 0,9% or Ringer Acetate or Lactate were allowed), administered in 10 minutes.
The Fluid challenge is administered by the attending physician to correct hemodynamic instability.
All the patients received hemodynamic monitoring with the MostCare system which provides all the hemodynamic variables evaluated in the study before and after fluid challenge administration (cardiac output, stroke volume, arterial elastance (Ea),
Fluid challenge consisting in 500 ml of intravenous crystalloids (both saline 0,9% or Ringer Acetate or Lactate were allowed), administered in 10 minutes. The Fluid challenge is administered by the attending physician to correct hemodynamic instability. All the patients received hemodynamic monitoring with the MostCare system which provides all the hemodynamic variables evaluated in the study before and after fluid challenge administration (cardiac output, stroke volume, arterial elastance (Ea), cardiac cycle efficiency (CCE)). In a previous pilot study a model including baseline pulse pressure variation, the variation of systolic arterial pressure - dicrotic pressure and CCE showed the greater AUC (0.92), and correctly identified the efficacy of FC in 87% of patients (84.2% of responders and 92.5 of non-responders). The following formula describes this latter model: 0.039+1.042*(DELTASAP- Pdic 5min)+1.278* DELTACCE5min+1.159*PPVbaseline
Sponsors
antonio messina
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Group 1 (ICU septic) and 2 (ICU non septic): Acute circulatory failure defined by a systolic arterial pressure less than or equal to 90 mm Hg (or fall of systolic arterial pressure higher or equal to 50 mm Hg in known hypertensive patients) and one or more of the following signs: 1) urinary flow less than or equal to 0.5 mL/kg/min for greater than or equal to 2 hours, 2) tachycardia greater than or equal to 100 bpm, or 3) presence of skin mottling.
Exclusion criteria
For ICU group the exclusion criteria are: 1) New York Heart Association (NYHA) class III or IV, or severe valvular diseases, or right ventricle systolic dysfunction; 2) cardiac arrhythmias; 3) severe ARDS (4); 4) haemodialysis or continuous hemofiltration; 5) any condition affecting arterial waveform including acute/chronic aortic dissection, thoracic outlet syndrome, subclavian artery stenosis and uncorrected under- or over-damping of the pressure thransducer.
Outcome results
None listed