Continuous Venovenous HemofiltrationNCT01362088
Microcirculation in Continuous Venovenous Hemofiltration Patients on the Intensive Care Unit
An observational study of Continuous Venovenous Hemofiltration, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial summary
In patients where fluid is withdrawn from the bloodstream by Continuous Venovenous Hemofiltration (CVVH), the ultrafiltration rate will be calculated for a zero balance. From there, the ultrafiltration steps are performed, after increasing the ultrafiltration rate, the sublingual microcirculation is assessed by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuous Venovenous Hemofiltration
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2011to Oct 2012
- 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: Intensive Care patients treated with CVVH
Who may be able to join
- age > 18 jaar
- informed consent
Who cannot join
- age < 18 jaar
- oral surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Sublingual Microcirculation by Means of SDF Imaging by Stepwise Ultrafiltration in CVVH Patients on the ICU
In patients where fluid is withdrawn from the bloodstream by Continuous Venovenous Hemofiltration (CVVH), the ultrafiltration rate will be calculated for a zero balance. From there, the ultrafiltration steps are performed, after increasing the ultrafiltration rate, the sublingual microcirculation is assessed by sidestream dark field (SDF). The images are subsequently randomly analyzed, and the sublingual microcirculation is expressed as a number, the microvascular flow index (MFI).
Read the detailed description
Before deciding to threat a patient actively with CVVH, a target balance will be agreed for the next 12 hours. Then the ultrafiltration rate for the zero balance is calculated. From there, the ultrafiltration rate progressively increased to 50 ml per hour, up to a maximum ultrafiltration rate of 300 ml per hour.
After each increase of the ultrafiltration rate, the sublingual microcirculation is assessed by SDF.
After obtaining the desired ultrafiltration rate, the microcirculation will again be assessed before and after the patient is temporarily placed in Trendelenburg position. This could possibly show that underfill has the greatest influence on the microcirculation, and not other factors like a rising hematocrit.
- Conditions
- Continuous Venovenous Hemofiltration
- Keywords
- microcirculation, intensive care, ultrafiltration, CVVH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CVVH patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in MFI between zero balance and maximal ultrafiltrationrate (300 ml/hr)
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startSep 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Continuous Venovenous HemofiltrationStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E.C. Boerma, Frisius Medisch Centrum
- Investigators
- Christiaan Boerma, MD, Principal investigator, Frisius Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362088
- Sponsor's protocol ID
- TPO 767
- Status last verified
- Oct 2012
- First submitted
- 11 May 2011
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bemelmans RH, Boerma EC, Barendregt J, Ince C, Rommes JH, Spronk PE. Changes in the volume status of haemodialysis patients are reflected in sublingual microvascular perfusion. Nephrol Dial Transplant. 2009 Nov;24(11):3487-92. doi: 10.1093/ndt/gfp267. Epub 2009 Jun 10.
PubMed 19515801
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sublingual Microcirculation by Means of SDF Imaging by Stepwise Ultrafiltration in CVVH Patients on the ICU
- ClinicalTrials.gov ID
- NCT01362088
- Acronym / sponsor ID
- TPO 767
- Conditions
- Continuous Venovenous Hemofiltration
- Keywords
- microcirculation, intensive care, ultrafiltration, CVVH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 27 May 2011 (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.
In patients where fluid is withdrawn from the bloodstream by Continuous Venovenous Hemofiltration (CVVH), the ultrafiltration rate will be calculated for a zero balance. From there, the ultrafiltration steps are performed, after increasing the ultrafiltration rate, the sublingual microcirculation is assessed by sidestream dark field (SDF). The images are subsequently randomly analyzed, and the sublingual microcirculation is expressed as a number, the microvascular flow index (MFI).
Detailed description
Before deciding to threat a patient actively with CVVH, a target balance will be agreed for the next 12 hours. Then the ultrafiltration rate for the zero balance is calculated. From there, the ultrafiltration rate progressively increased to 50 ml per hour, up to a maximum ultrafiltration rate of 300 ml per hour.
After each increase of the ultrafiltration rate, the sublingual microcirculation is assessed by SDF.
After obtaining the desired ultrafiltration rate, the microcirculation will again be assessed before and after the patient is temporarily placed in Trendelenburg position. This could possibly show that underfill has the greatest influence on the microcirculation, and not other factors like a rising hematocrit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CVVH patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive Care patients treated with CVVH
Key inclusion criteria (2 listed)
- age > 18 jaar
- informed consent
Key exclusion criteria (2 listed)
- age < 18 jaar
- oral surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in MFI between zero balance and maximal ultrafiltrationrate (300 ml/hr)
Time frame: 4 hours
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 1 Nov 2012.
- Background: PubMed 19515801Bemelmans RH, Boerma EC, Barendregt J, Ince C, Rommes JH, Spronk PE. Changes in the volume status of haemodialysis patients are reflected in sublingual microvascular perfusion. Nephrol Dial Transplant. 2009 Nov;24(11):3487-92. doi: 10.1093/ndt/gfp267. Epub 2009 Jun 10.
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.
Christiaan Boerma, MD 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 Continuous Venovenous Hemofiltration, 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 2 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 1 Nov 2012. 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 MFI between zero balance and maximal ultrafiltrationrate (300 ml/hr) (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01362088, which also lists 1 linked publication.
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 1 Nov 2012.