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

NCT02661269 | Completed

• 1 other identifier: nWMO 127
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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)

Conditions

Edema; Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Septic patients

Septic patients with fluid overload (fluid balance + 4 L)

Device: Videomicroscopy of the sublingual microcirculation; Device: Bio-impedance measurements.

Post-cardiac surgery patients

Patients after cardiac surgery, at arrival on ICU.

Device: Videomicroscopy of the sublingual microcirculation; Device: Bio-impedance measurements.

Interventions

Videomicroscopy of the sublingual microcirculation DEVICE

Measuring total vessel density with the Cytocam-IDF camera.

Post-cardiac surgery patients; Septic patients

Bio-impedance measurements. DEVICE

measuring resistance and reactance with the BIVA method.

Post-cardiac surgery patients; Septic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

ICU population

You may qualify if:

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

You may not qualify if:

• recent maxillofacial surgery

Sponsors & Collaborators

• Frisius Medisch Centrum: lead

Study Sites (1)

Medical Centre Leeuwarden

Leeuwarden, Provincie Friesland, 8901 BR, Netherlands

Location

MeSH Terms

Conditions

Edema; Sepsis

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes

Study Officials

• E.C. Boerma, MD-PhD

  Frisius Medisch Centrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: January 22, 2016
• Study Start: November 1, 2015
• Primary Completion: February 15, 2018
• Study Completion: February 15, 2018
• Last Updated: March 27, 2018

Record last verified: 2017-03

Locations

NL (1)