Fluid Challenge Infusion and Response (REFILL)
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|ClinicalTrials.gov Identifier: NCT03810118|
Recruitment Status : Completed
First Posted : January 18, 2019
Last Update Posted : May 27, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Neurosurgery Cardiovascular System Anesthesia, General||Diagnostic Test: fluid challenge||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A single group of patient will receive 4 ml/kg fluid challenge in either 10 or 20 minutes|
|Masking:||None (Open Label)|
|Official Title:||Rate of Fluid Challenge Administration and Fluid Responsiveness: an Open-label, Multicentric, Randomized Clinical Trial.|
|Actual Study Start Date :||April 8, 2019|
|Actual Primary Completion Date :||February 21, 2020|
|Actual Study Completion Date :||May 1, 2020|
All the enrolled patients will receive the same mini-fluid challenge test of 100ml and then will complete the 4 ml/kg fluid challenge in either 10 or 20 minutes
Diagnostic Test: fluid challenge
4 ml/kg fluid challenge infused over in either 10 or 20 minutes
- Percentage of fluid responders [ Time Frame: 10 or 20 minutes from the start ]Percentage of patients showing an increase in the stroke volume above the predefined threshold of fluid responsiveness after the infusion of the fluid challenge (>10%).
- Pharmacodynamic effect of the FC [ Time Frame: 10 or 20 minutes from the start ]AUC
- Pharmacodynamic effect of the FC [ Time Frame: 10 or 20 minutes from the start ]dmax
- Pharmacodynamic effect of the FC [ Time Frame: 10 or 20 minutes from the start ]Tmax
- Pharmacodynamic effect of the FC [ Time Frame: 10 or 20 minutes from the start ]d1
- Pharmacodynamic effect of the FC [ Time Frame: 10 or 20 minutes from the start ]d5
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810118
|Humanitas Research Hospital|
|Rozzano, Milano, Italy, 20089|