EdemaNCT02661269
Relation Between the Increase of Peripheral Edema by Fluid Therapy and the Decrease in Microcirculatory Vesseldensity
An observational study of Edema and Sepsis, run by Frisius Medisch Centrum at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Videomicroscopy of the sublingual microcirculation and Bio-impedance measurements.
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2015to 15 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU population
Who may be able to join
- after cardiac surgery
- septic patient with a fluid balance of 4L +
Who cannot join
- recent maxillofacial surgery
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Medical Centre Leeuwarden
Leeuwarden, Provincie Friesland, 8901 BR
About this study
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)
Read the 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.
- Being tested
- Videomicroscopy of the sublingual microcirculation, Bio-impedance measurements.
- Medical subject headings
- Edema, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videomicroscopy of the sublingual microcirculationDevice
Measuring total vessel density with the Cytocam-IDF camera.
Bio-impedance measurements.Device
measuring resistance and reactance with the BIVA method.
| Study group | Role | What they receive |
|---|---|---|
| Septic patients | Septic patients with fluid overload (fluid balance + 4 L) Receives: Device: Videomicroscopy of the sublingual microcirculation; Device: Bio-impedance measurements. | |
| Post-cardiac surgery patients | Patients after cardiac surgery, at arrival on ICU. Receives: Device: Videomicroscopy of the sublingual microcirculation; Device: Bio-impedance measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study start1 Nov 2015
- Primary completion15 Feb 2018
- Study completion15 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerke Veenstra, Frisius Medisch Centrum
- Investigators
- E.C. Boerma, MD-PhD, Principal investigator, Frisius Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661269
- Sponsor's protocol ID
- nWMO 127
- Status last verified
- Mar 2017
- First submitted
- 2 Dec 2015
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between the Increase of Peripheral Edema by Fluid Therapy and the Decrease in Microcirculatory Vesseldensity
- ClinicalTrials.gov ID
- NCT02661269
- Acronym / sponsor ID
- nWMO 127
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septic patients | – | Device: Videomicroscopy of the sublingual microcirculation, Device: Bio-impedance measurements.Septic patients with fluid overload (fluid balance + 4 L) |
| Post-cardiac surgery patients | – | Device: Videomicroscopy of the sublingual microcirculation, Device: Bio-impedance measurements.Patients after cardiac surgery, at arrival on ICU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU population
Key inclusion criteria (2 listed)
- after cardiac surgery
- septic patient with a fluid balance of 4L +
Key exclusion criteria (1 listed)
- recent maxillofacial surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Videomicroscopy of the sublingual microcirculationMeasuring total vessel density with the Cytocam-IDF camera. | Device | Post-cardiac surgery patients, Septic patients |
| Bio-impedance measurements.measuring resistance and reactance with the BIVA method. | Device | Post-cardiac surgery patients, Septic patients |
Primary outcome
Difference in vessel density (mm/mm2) of the sublingual microcirculation between the two groups.
Time frame: 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.
1 secondary outcome
The correlation between a increasing fluid balance and the total vessel density in both groups separately.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E.C. Boerma, MD-PhD principal investigator
Frisius Medisch Centrum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edema and Sepsis, run by Frisius Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in vessel density (mm/mm2) of the sublingual microcirculation between the two groups. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.