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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02661269
• Other study ID #: nWMO 127
• Status: Completed
• First received: December 2, 2015
• Last updated: March 26, 2018
• Start date: November 1, 2015
• Est. completion date: February 15, 2018

Study information

• Verified date: March 2017
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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)

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 15, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• after cardiac surgery

• septic patient with a fluid balance of 4L +

Exclusion Criteria:

• recent maxillofacial surgery

Related Conditions & MeSH terms

• Edema
• Sepsis

Intervention

Device:
• Videomicroscopy of the sublingual microcirculation
Measuring total vessel density with the Cytocam-IDF camera.
• Bio-impedance measurements.
measuring resistance and reactance with the BIVA method.

Locations

Country	Name	City	State
Netherlands	Medical Centre Leeuwarden	Leeuwarden	Friesland

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Secondary	The correlation between a increasing fluid balance and the total vessel density in both groups separately.		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.