- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Friesland
-
Leeuwarden, Friesland, Nederland, 8901 BR
- Medical Centre Leeuwarden
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- after cardiac surgery
- septic patient with a fluid balance of 4L +
Exclusion Criteria:
- recent maxillofacial surgery
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Septic patients
Septic patients with fluid overload (fluid balance + 4 L)
|
Measuring total vessel density with the Cytocam-IDF camera.
measuring resistance and reactance with the BIVA method.
|
|
Post-cardiac surgery patients
Patients after cardiac surgery, at arrival on ICU.
|
Measuring total vessel density with the Cytocam-IDF camera.
measuring resistance and reactance with the BIVA method.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in vessel density (mm/mm2) of the sublingual microcirculation between the two groups.
Tidsramme: 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. |
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.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The correlation between a increasing fluid balance and the total vessel density in both groups separately.
Tidsramme: 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.
|
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.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: E.C. Boerma, MD-PhD, Medical Centre Leeuwarden
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- nWMO 127
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