Fluid Challenges and Microcirculation

NCT ID: NCT04559178

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-25

Study Completion Date

2021-08-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Fluid challenge

fluid challenge administration when patient is in the gray zone

Intervention Type OTHER

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Alexandre Joosten, MD PhD

Study Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexandre JOOSTEN, MD PhD

Role: STUDY_DIRECTOR

ERASME

Alexandra Colesnicenco, MD

Role: PRINCIPAL_INVESTIGATOR

ERASME

Locations

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Bicetre hospital

Le Kremlin-Bicêtre, Val De Marne, France

Site Status

Countries

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France

Other Identifiers

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P2020/338 / B4062020000092

Identifier Type: -

Identifier Source: org_study_id

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