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

Completed

• Conditions: Edema; Sepsis
• Interventions: Device: Videomicroscopy of the sublingual microcirculation; Device: Bio-impedance measurements.

• Registration Number: NCT02661269
• Lead Sponsor: Medical Centre Leeuwarden

Brief 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)

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 Timeline

• Study Start: 2015-11-01
• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2016-01-19
• Study First Posted: 2016-01-22
• Status Verified: 2017-03
• Primary Completion: 2018-02-15
• Study Completion: 2018-02-15
• Last Update Submitted: 2018-03-26
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

Exclusion Criteria

• recent maxillofacial surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-cardiac surgery patients	Videomicroscopy of the sublingual microcirculation	Patients after cardiac surgery, at arrival on ICU.
Septic patients	Videomicroscopy of the sublingual microcirculation	Septic patients with fluid overload (fluid balance + 4 L)
Septic patients	Bio-impedance measurements.	Septic patients with fluid overload (fluid balance + 4 L)
Post-cardiac surgery patients	Bio-impedance measurements.	Patients after cardiac surgery, at arrival on ICU.

Primary Outcome Measures

Name	Time	Method
Difference in vessel density (mm/mm2) of the sublingual microcirculation between the two groups.	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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Medical Centre Leeuwarden; 🇳🇱 Leeuwarden, Friesland, Netherlands