Anesthesia, General Clinical Trial
Official title:
Rate of Fluid Challenge Administration and Fluid Responsiveness: an Open-label, Multicentric, Randomized Clinical Trial.
It is unclear if the rate of administration of the fluid challenge could affect the rate of
fluid responsiveness.
The role of this small-dose (the so called mini-FC) has been recently tested to assess if the
infusion of a small amount of fluids (100 ml in 1 minute) could predict the final effect of
the residual aliquot (i.e., 250 ml of FC test subdivided as follows: 100 ml in 1 minute and
150 ml in 9 minutes). Both the sudden increase in the stroke volume and the reduction of PPV
and SVV after a bolus of 100 ml of crystalloids administered in 1 minute showed high
sensitivity and specificity in predicting the final outcome of the FC.
The primary aim of the present study is assess whether the does the rate of infusion of fluid
challenge affect fluid responsiveness in neurosurgical supine patients.
The secondary aim is to assess the reliability of the changes in SV, PPV and SVV after a
mini-FC test in predicting the final fluid responsiveness.
Dedicated algorithms and protocols of anaesthetic care regarding fluid therapy are key
factors to prevent perioperative hypovolaemia and/or hypervolemia, which are known to
increase morbidity and length of hospital stay.
Fluid therapy is commonly used in critically ill and surgical patients to restore
hemodynamics. The aim of volume expansion is to increase cardiac index and oxygen delivery
and to improve tissue oxygenation. However, this occurs only in a situation of preload
dependency (i.e. when the ventricle operates on the steep part of the Frank-Starling's
curve). Moreover, giving fluids to a non-volume-responsive patient (preload independency) can
result in detrimental pulmonary and interstitial oedema. Fluid responsiveness (i.e., increase
in stroke volume, SV, after fluid challenge, FC, administration) can be detected in 35-50% of
both critically ill and surgical patients. The FC consists in assessing the hemodynamic
effects of giving a small amount of fluid in a short period of time. The FC allows restoring
fluid depletion when indicated, while minimizing the risk of overloading, which makes it the
gold standard for assessing fluid depletion in patients undergoing surgery.
Then, FC administration should be based on predictors of fluid responsiveness. Static
indexes, such as the central venous pressure, do not seem appropriate, whereas dynamic
indexes, such as pulse pressure variation (PPV) and stroke volume variation (SVV), reliably
predict the effect of FC administration during controlled mechanical ventilation only in case
of a tidal volume (VT) of at least 8 mL/kg, which unfortunately are rarely found in both
critically ill and surgical patients.
To overcome this VT-related limitation of PPV and SVV, the prediction of fluid responsiveness
can be also achieved by applying functional hemodynamic tests aiming at increasing venous
return and enhancing right ventricle preload dependence.
For example, when a FC is performed using a rapid infusion rate and a relatively "small"
dose, its effect is sufficient to test whether the patient is on the ascending part of the
cardiac function curve, hence showing an increase in cardiac output (CO).
The role of this small-dose (the so called mini-FC) has been recently tested to assess if the
infusion of a small amount of fluids (100 ml in 1 minute) could predict the final effect of
the residual aliquot (i.e., 250 ml of FC test subdivided as follows: 100 ml in 1 minute and
150 ml in 9 minutes). Both the sudden increase in the stroke volume and the reduction of PPV
and SVV after a bolus of 100 ml of crystalloids administered in 1 minute showed high
sensitivity and specificity in predicting the final outcome of the FC. However, the mini-FC
has been tested, insofar, only in small-sized studies, needing further investigations to be
confirmed.
Moreover, the response to the FC is transitory, and as such also its clinical effect. The
study of Aya et al. pointed out that the effect of the FC is dissipated in about 10 minutes
in both responders and non-responders and that a dose of 4 ml/kg of crystalloids is the
lowest one to evocate a significant hemodynamic effect. It remains unclear, however, what the
best approach to FC administration should be and, in fact, wide variability exists at this
regard among studies performed both in the perioperative setting and in the intensive care
unit (ICU). In fact, the rate of fluid administration is not fixed. A recent systematic
review showed a significant heterogeneity. In a subgroup of 35 studies three (8.6%) reported
an infusion rate of 1 ml/kg/min. In another group of 32 studies, the FC was administered in
30 minutes in 7 (21.8%) studies, in 20 minutes in 2 (6.2%) studies, in 13 minutes in 1 (3.1%)
study, in 10 minutes in 15 studies (46.8%), in 5 minutes in 4 (12.5%) studies, in 3 minutes
in 1 (3.1%) study, and in 2 minutes in 2 (6.2%) studies. The median (IQR) time of infusion
was 10 (5-20) minutes.
After the indication of Aya et al., 4 ml/kg of crystalloids is the standard dose for the FC
in our center. However, it is unclear if the rate of administration could affect the rate of
fluid responsiveness. We, therefore, will perform a study to address this issue in a sample
of neurosurgical patients.
The primary aim of the present study is assess whether the does the rate of infusion of fluid
challenge affect fluid responsiveness in neurosurgical patients.
The secondary aim is to assess the reliability of the changes in SV, PPV and SVV after a
mini-FC test in predicting the final fluid responsiveness.
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