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Completed

NCT Number: NCT02661269

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

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)

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Key information

Conditions

Edema Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Centre Leeuwarden

Leeuwarden, Provincie Friesland, 8901 BR, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • recent maxillofacial surgery

Treatment and study plan

Videomicroscopy of the sublingual microcirculation

Device

Measuring total vessel density with the Cytocam-IDF camera.

Bio-impedance measurements.

Device

measuring resistance and reactance with the BIVA method.

Primary outcomes

  1. Difference in vessel density (mm/mm2) of the sublingual microcirculation between the two groups.

    Time frame: Cardiac surgery within 4 hours of ICU admittance, 1 offline total vessel density measurement, Septic patients +/- third day of ICU admittance, 1 offline total vessel density measurement.

    With the Cytocam-IDF we make movies off the sublingual microcirculation for 6 seconds on 3 different spots, with offline analysis we calculate a mean total vessel density (total surface of vessels divided by total area surface).

    The cardiac surgery group will be measured within 4 hours of admittance on the ICU. The septic patients group will be measured on the moment that the highest fluid balance during the ICU stay, so on the moment that there will be started with diuretics of renal replacement therapy to induce a negative fluid balance.

Secondary outcomes

  1. The correlation between a increasing fluid balance and the total vessel density in both groups separately.

    Time frame: The cumulative fluidbalance (L) will be noted at the same moment as the microcirculation movies are made, this will be the cumulative fluid balance as measured on the ICU.

Sponsors and collaborators

Lead sponsor

Frisius Medisch Centrum

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 22, 2016
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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