Relation Between the Increase of Peripheral Edema by Fluid Therapy and the Decrease in Microcirculatory Vesseldensity

NCT ID: NCT02661269

Last Updated: 2018-03-27

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

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-01

Study Completion Date

2018-02-15

Brief Summary

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Can videomicroscopy of the sublingual microcirculation detect the increase in edema before peripheral edema will appear? By measuring the decrease in vesseldensity after strong positive fluid balances within septic patients versus euvolemic post-cardiac surgery patients. Measuring reactance and resistance (BIVA method) to determine volume status.

Primary outcome:

\- Total vessel density (TVD)

Secondary outcome:

* Fluid balance
* BIVA measurements (reactance \& resistance)

Detailed Description

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There are a lot of methods to determine if a patient is fluid-responsive, however a moment to stop fluid therapy is lacking. So the purpose of this study is to find a 'stop' moment for fluid therapy before peripheral edema will be present.

With sublingual measurements of the vessel density with the Cytocam-IDF, comparing the septic patients with fluid overload , euvolemic post-cardiac surgery patients at the arrival on the ICU and healthy volunteers we can determine if there is a decrease in vessel density during fluid loading.

To give a accurate view on fluid overload we include a bio-impedance measurement of reactance and resistance. Fluid balances are recorded very accurate by our electronic patient record.

Conditions

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Edema Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Septic patients

Septic patients with fluid overload (fluid balance + 4 L)

Videomicroscopy of the sublingual microcirculation

Intervention Type DEVICE

Measuring total vessel density with the Cytocam-IDF camera.

Bio-impedance measurements.

Intervention Type DEVICE

measuring resistance and reactance with the BIVA method.

Post-cardiac surgery patients

Patients after cardiac surgery, at arrival on ICU.

Videomicroscopy of the sublingual microcirculation

Intervention Type DEVICE

Measuring total vessel density with the Cytocam-IDF camera.

Bio-impedance measurements.

Intervention Type DEVICE

measuring resistance and reactance with the BIVA method.

Interventions

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Videomicroscopy of the sublingual microcirculation

Measuring total vessel density with the Cytocam-IDF camera.

Intervention Type DEVICE

Bio-impedance measurements.

measuring resistance and reactance with the BIVA method.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* after cardiac surgery
* septic patient with a fluid balance of 4L +

Exclusion Criteria

* recent maxillofacial surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Frisius Medisch Centrum

OTHER

Sponsor Role lead

Responsible Party

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Gerke Veenstra

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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E.C. Boerma, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Frisius Medisch Centrum

Locations

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Medical Centre Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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nWMO 127

Identifier Type: -

Identifier Source: org_study_id

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