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Intraoperative Fluid Responsiveness After Mini Fluid Challenge. (REFILL)

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ClinicalTrials.gov Identifier: NCT03810118
Recruitment Status : Not yet recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Antonio Messina, Humanitas Clinical and Research Center

Brief 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.


Condition or disease Intervention/treatment Phase
Neurosurgery Cardiovascular System Anesthesia, General Diagnostic Test: fluid challenge Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A single group of patient 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
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Intraoperative Fluid Responsiveness After Mini Fluid Challenge: an Open-label, Multicentric, Randomized Clinical Trial.
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Treatment
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
A first aliquot of a of 100ml mini FC infused over 1 minute, followed by a the rest aliquot of a 4 ml/kg fluid challenge infused over in either 10 or 20 minutes




Primary Outcome Measures :
  1. 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%).


Secondary Outcome Measures :
  1. Pulse pressure Variation (PPV) changes between baseline and after mini-FC test [ Time Frame: 1 minute ]
    To assess the sensitivity and specificity of PPV changes after the mini-FC test (100 ml administered in 1 minute) in predicting fluid responsiveness. This change will be assessed by a continuous measurement of PPV obtained by means of MOSTCARE(TM) system.

  2. Stroke volume changes between baseline and after mini-FC test [ Time Frame: 1 minute ]
    To assess the sensitivity and specificity of the stroke volume changes after the mini-FC test (100 ml administered in 1 minute) in predicting fluid responsiveness. This change will be assessed by a continuous measurement of stroke volume obtained by means of MOSTCARE(TM) system.

  3. Stroke volume variation (SVV) changes between baseline and after mini-FC test [ Time Frame: 1 minute ]
    o assess the sensitivity and specificity of PPV changes after the mini-FC test (100 ml administered in 1 minute) in predicting fluid responsiveness. This change will be assessed by a continuous measurement of SVV obtained by means of MOSTCARE(TM) system.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients aged ≥ 18 years;
  2. Scheduled for elective supine neurosurgery and requiring invasive arterial monitoring;
  3. Glasgow coma scale 15 at recruitment

Exclusion Criteria:

  1. Any recurrent cardiac arrhythmias;
  2. Reduced left (ejection fraction <30%) or right (systolic peak velocity of tricuspid annular motion <0.17 m/s) ventricular systolic function;
  3. Intra-operative use of vasopressors or inotropes before FC administration or between the first and the second bolus of fluids.
  4. Chronic use beta-blocking agents.

Information from the National Library of Medicine

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


Locations
Italy
Humanitas Research Hospital Not yet recruiting
Rozzano, Milano, Italy, 20089
Contact: Antonio Messina, MD    +390282241    antonio.messina@humanitas.it   
Sponsors and Collaborators
Humanitas Clinical and Research Center

Publications of Results:
Responsible Party: Antonio Messina, ICU senior consultant, Humanitas Clinical and Research Center
ClinicalTrials.gov Identifier: NCT03810118     History of Changes
Other Study ID Numbers: REFILL
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No