Fluid Challenges and Microcirculation (FC)

Impact of Intraoperative Fluid Challenges Administration on Macro and Microcirculation in Patients Undergoing High-risk Abdominal Surgery and Situated in the Gray Zone of Pulse Pressure Variation

The goal of this prospective observational study is to assess the impact of fluid challenge administration on macro and microcirculation in patients situated in the gray zone during a high risk abdominal surgery

Study Overview

• Status: Terminated
• Conditions: Surgery
• Intervention / Treatment: Other: Fluid challenge

Detailed Description

Fluid optimization is a key goal in anesthesia. It allows to titrate fluid bolus based on flow variables or dynamic parameters of fluid responsiveness (pulse pressure variation (PPV) or stroke volume variation (SVV)).

When PPV or SVV is above 13%, the patient will usually respond to a bolus of fluid while when PPV or SVV is below 9%, the patient will normally not respond to it. Between 9% and 13%, it is a gray zone where the effect of a fluid bolus is uncertain.

The overall goal of fluid bolus administration is of course to optimize macrocirculation (stroke volume and cardiac output) but also (and probably more importantly) end organ tissue perfusion. However, regional tissue perfusion is not widely monitored during surgery. However, we do have some monitoring tools to assess microcirculation at the bedside.

Investigation of microcirculation in addition to macro circulation may allow clinicians to know if a patient situated in the gray zone may or not increase microcirculation variables while macrocirculation variables are well known to be of little value to predict fluid responsiveness.

The goal of this study is to assess microcirculation variables in patients situated in the gray zone (PPV between 9%-13%), and to assess macro and microcirculation responses to a standardized fluid challenge of 4 ml/kg of a balanced crystalloid solution.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• France
  • Val De Marne
    • Le Kremlin-Bicêtre, Val De Marne, France, 94270
      • Bicetre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for a high-risk abdominal surgery and equipped with a minimally uncalibrated pulse contour analysis monitoring device as part of their anesthetic care.

All patients will have the hemodynamic monintoring to assess macrocirculation and sublingual microcirculation.

Description

Inclusion Criteria:

• Patients undergoing a high-risk abdominal surgery
• Patients equipped with a minimally invasive cardiac output monitoring device in order to optimize fluid administration

Exclusion Criteria:

• Atrial fibrillation
• Ejection fraction <40%

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microvascular flow index	Comparison of this index before and after the fluid challenge	day 0

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Study Director: Alexandre JOOSTEN, MD PhD, Erasme; Principal Investigator: Alexandra Colesnicenco, MD, Erasme

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 19, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: P2020/338 / B4062020000092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No