CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 49 enrolled
Drug / intervention
fluid challengeother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03810118
NCT03810118N/ACompleted

Rate of Fluid Challenge Administration and Fluid Responsiveness: an Open-label, Multicentric, Randomized Clinical Trial.

Humanitas Clinical and Research Center·interventional·Posted Jan 18, 2019·Updated May 27, 2020

In Brief

A clinical study evaluating fluid challenge for Neurosurgery and 2 related conditions. Completed, enrolled 49 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 18, 2019
Enrollment StartApr 8, 2019
Primary CompletionFeb 21, 2020
Study CompletionMay 1, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.5 years ago

Interventions

fluid challengeother

4 ml/kg fluid challenge infused over in either 10 or 20 minutes