An observational study in Edema and Sepsis, sponsored by Medical Centre Leeuwarden. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-27.
Sponsored by Medical Centre Leeuwarden · Observational
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:
Secondary outcome:
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.
825 studies on the registry are indexed under Edema; 91 are open to participants now.
This study's enrollment of 110 is above the median of 71 across 171 observational studies indexed under Edema.
Browse Edema studies →Medical Centre Leeuwarden is the lead sponsor of 41 studies on the registry; 6 are open to participants now.
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ICU population
Exclusion Criteria:
Septic patients with fluid overload (fluid balance + 4 L)
Device: Videomicroscopy of the sublingual microcirculation · Device: Bio-impedance measurements.
Patients after cardiac surgery, at arrival on ICU.
Device: Videomicroscopy of the sublingual microcirculation · Device: Bio-impedance measurements.
Measuring total vessel density with the Cytocam-IDF camera.
measuring resistance and reactance with the BIVA method.
Difference in vessel density (mm/mm2) of the sublingual microcirculation between the two groups.
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.
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.
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.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Medical Centre Leeuwarden