Fluid Challenges and Microcirculation

Surgery Clinical Trial

— FC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04559178
• Other study ID #: P2020/338 / B4062020000092
• Status: Terminated
• Start date: January 25, 2021
• Est. completion date: August 30, 2021

Study information

• Verified date: September 2022
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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%

Related Conditions & MeSH terms

• Surgery

Intervention

Other:
• Fluid challenge
fluid challenge administration when patient is in the gray zone

Locations

Country	Name	City	State
France	Bicetre hospital	Le Kremlin-Bicêtre	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microvascular flow index	Comparison of this index before and after the fluid challenge	day 0