Fluid Challenge Infusion and Response

NCT03810118 | Completed

• 1 other identifier: REFILL
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurosurgery; Cardiovascular System; Anesthesia, General

Outcome Measures

Primary Outcomes (6)

• Percentage of fluid responders

  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%).

  10 or 20 minutes from the start

• Pharmacodynamic effect of the FC

  AUC

  10 or 20 minutes from the start

• Pharmacodynamic effect of the FC

  dmax

  10 or 20 minutes from the start

• Pharmacodynamic effect of the FC

  Tmax

  10 or 20 minutes from the start

• Pharmacodynamic effect of the FC

  d1

  10 or 20 minutes from the start

• Pharmacodynamic effect of the FC

  d5

  10 or 20 minutes from the start

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

fluid challenge DIAGNOSTIC_TEST

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Humanitas Clinical and Research Center: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Location

Related Publications (4)

• Mahjoub Y, Lejeune V, Muller L, Perbet S, Zieleskiewicz L, Bart F, Veber B, Paugam-Burtz C, Jaber S, Ayham A, Zogheib E, Lasocki S, Vieillard-Baron A, Quintard H, Joannes-Boyau O, Plantefeve G, Montravers P, Duperret S, Lakhdari M, Ammenouche N, Lorne E, Slama M, Dupont H. Evaluation of pulse pressure variation validity criteria in critically ill patients: a prospective observational multicentre point-prevalence study. Br J Anaesth. 2014 Apr;112(4):681-5. doi: 10.1093/bja/aet442. Epub 2013 Dec 29.

  PMID: 24374504 RESULT

• Biais M, de Courson H, Lanchon R, Pereira B, Bardonneau G, Griton M, Sesay M, Nouette-Gaulain K. Mini-fluid Challenge of 100 ml of Crystalloid Predicts Fluid Responsiveness in the Operating Room. Anesthesiology. 2017 Sep;127(3):450-456. doi: 10.1097/ALN.0000000000001753.

  PMID: 28640019 RESULT

• Muller L, Toumi M, Bousquet PJ, Riu-Poulenc B, Louart G, Candela D, Zoric L, Suehs C, de La Coussaye JE, Molinari N, Lefrant JY; AzuRea Group. An increase in aortic blood flow after an infusion of 100 ml colloid over 1 minute can predict fluid responsiveness: the mini-fluid challenge study. Anesthesiology. 2011 Sep;115(3):541-7. doi: 10.1097/ALN.0b013e318229a500.

  PMID: 21792056 RESULT

• Aya HD, Ster IC, Fletcher N, Grounds RM, Rhodes A, Cecconi M. Pharmacodynamic Analysis of a Fluid Challenge. Crit Care Med. 2016 May;44(5):880-91. doi: 10.1097/CCM.0000000000001517.

  PMID: 26683506 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ICU senior consultant

Model Details: A single group of patient will receive 4 ml/kg fluid challenge in either 10 or 20 minutes

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 18, 2019
• Study Start: April 8, 2019
• Primary Completion: February 21, 2020
• Study Completion: May 1, 2020
• Last Updated: May 27, 2020

Record last verified: 2020-05

Locations

IT (1)