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)

Study Overview

• Status: Completed
• Conditions: Sepsis; Edema
• Intervention / Treatment: Device: Videomicroscopy of the sublingual microcirculation; Device: Bio-impedance measurements.

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Netherlands
  • Friesland
    • Leeuwarden, Friesland, Netherlands, 8901 BR
      • Medical Centre Leeuwarden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

ICU population

Description

Inclusion Criteria:

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

Exclusion Criteria:

• recent maxillofacial surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Septic patients; Septic patients with fluid overload (fluid balance + 4 L)	Device: Videomicroscopy of the sublingual microcirculation; Measuring total vessel density with the Cytocam-IDF camera.; Device: Bio-impedance measurements.; measuring resistance and reactance with the BIVA method.
Post-cardiac surgery patients; Patients after cardiac surgery, at arrival on ICU.	Device: Videomicroscopy of the sublingual microcirculation; Measuring total vessel density with the Cytocam-IDF camera.; Device: Bio-impedance measurements.; measuring resistance and reactance with the BIVA method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Medical Centre Leeuwarden
• Investigators: Principal Investigator: E.C. Boerma, MD-PhD, Medical Centre Leeuwarden

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): February 15, 2018
• Study Completion (Actual): February 15, 2018

Study Registration Dates

• First Submitted: December 2, 2015
• First Submitted That Met QC Criteria: January 19, 2016
• First Posted (Estimate): January 22, 2016

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 26, 2018
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Edema
• Other Study ID Numbers: nWMO 127