RecruitingACTRN12617000076370

Validation of a novel algorithm for dynamic assessment of fluid challenge: a multicentric study

Sponsor

antonio messina

Enrollment

82 participants

Start Date

Jul 1, 2017

Study Type

Interventional

Conditions

Acute circulatory failure Hypoperfusion Hypotension

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This ICU study is testing a new way to decide whether giving extra fluids to a critically ill patient with low blood pressure will actually help them. Currently, doctors look at one blood pressure measurement to guide this decision, but that method is not always reliable. This study tests a new algorithm that looks at several measurements together to better predict whether fluid will benefit each patient. The fluid is given as part of standard care — the algorithm results are reviewed after the fact. You may be eligible if: - You are 18 years old or older - You are in an ICU with signs of poor circulation, including low blood pressure (systolic blood pressure at or below 90 mmHg) PLUS at least one of: low urine output, fast heart rate (over 100 beats per minute), or skin mottling You may NOT be eligible if: - You have severe heart failure (NYHA Class III or IV) or serious heart valve disease - You have cardiac arrhythmias (irregular heartbeat) - You have severe acute respiratory distress syndrome (ARDS) - You are on dialysis or continuous kidney filtration - You have a condition affecting the shape of the arterial pressure wave, such as aortic dissection Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 a

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