SurgeryNCT02675725
Kinetics of the Sublingual Microcirculation During Fluid Bolus
An observational study of Surgery and Hypovolemic Shock, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial summary
Fluid therapy is one of the cornerstones of the treatment of organ failure. The investigators assume that fluid bolus will increase the delivery of oxygen to the cells and resolve the shock. The purpose of this study is to asses kinetics of the sublingual microcirculation in one place during a fluid bolus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Hypovolemic Shock
- What is being tested?
- Measurement of sublingual microcirculation with Cytocam-IDF camera
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 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: Postoperative cardiac surgery patients
Who may be able to join
- > 18 years old
- post-cardiac surgery and need for fluid therapy
Who cannot join
- recent maxillofacial surgery
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Medical Centre Leeuwarden
Leeuwarden, Provincie Friesland, 8934 AD
About this study
Official title: Kinetics of the Sublingual Microcirculation During the Treatment of a Postoperative Shock
Fluid therapy is one of the cornerstones of the treatment of organ failure. The investigators assume that fluid bolus will increase the delivery of oxygen to the cells and resolve the shock.
The purpose of this study is to asses kinetics of the sublingual microcirculation in one place during a fluid bolus. It is expected that fluid therapy after normalization of the red blood cell flow velocity in the microcirculation will result in a decrease in capillary density through the formation of edema in the tissues. This can be considered to be the tipping of potentially beneficial to deleterious effects of fluid therapy.
After cardiac surgery patient will be transferred to the ICU for further stabilisation. Within specific indications the patient will receive a fluid bolus, these indications are hypotension, hyperlactataemia, tachycardia or decreased urine production. The fluid bolus will be 250 ml crystalloids in 15 minutes. The investigators will observe the sublingual microcirculation during this fluid bolus. To asses the red blood cell velocity and capillary vessel density on one spot during this fluid bolus.
Read the detailed description
Fluid therapy is one of the cornerstones of the treatment of organ failure. The investigators assume that a fluid bolus will increase the delivery of oxygen to the cells and resolve the shock. The evaluation of this treatment is done by clinical signs of organ perfusion en (little used) invasive hemodynamic monitoring. Previous research suggests that in-vivo microscopy of the microcirculation can be of importance to determine the type of shock and the reaction on treatment on tissue level.
Evaluation of the microcirculation was done by measuring red blood cell velocity on three different sites in the sublingual region. This was necessary in order to take heterogeneity into account, it was very hard to fix the camera on one spot during the observation period.
The purpose of this study is to asses kinetics of the sublingual microcirculation in one place during a fluid bolus. The great advantage is that the recordings before and after fluid therapy can be compared with each other as paired data, wherein the subject is its own control. By choosing a time interval that is long enough for the observation of the changes, but short enough for manual fixing of the camera, it seems possible to serve both purposes (15-30 minutes). This seems crucial now because both red blood cell flow as capillary density will be measured. It is expected that fluid therapy after normalization of the red blood cell flow velocity in the microcirculation will result in a decrease in capillary density through the formation of edema in the tissues. This can be considered to be the tipping of potentially beneficial to deleterious effects of fluid therapy.
After cardiac surgery patient will be transferred to the ICU for further stabilisation. Within specific indications the patient will receive a fluid bolus, these indications are hypotension, hyperlactataemia, tachycardia or decreased urine production. The fluid bolus will be 250 ml crystalloids in 15 minutes. The investigators will observe the sublingual microcirculation during this fluid bolus. To asses the red blood cell velocity and capillary vessel density on one spot during this fluid bolus.
- Conditions
- Surgery, Hypovolemic Shock
- Being tested
- Measurement of sublingual microcirculation with Cytocam-IDF camera
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of sublingual microcirculation with Cytocam-IDF cameraDevice
The normal treatment of a post-cardiac surgery patient is fluid bolus by indication. This indications are hypotension, hyperlactataemia, tachycardia or decreased urine production. This fluid bolus is 250 ml crystalloids in 15 minutes.
When this fluid bolus will be given, the investigators will observe the sublingual microcirculation and measure the red blood cell velocity and total vessel density on one spot for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Post cardiac surgery | Patients after cardiac surgery with signs of decreased organ perfusion and the need of fluid therapy. Receives: Device: Measurement of sublingual microcirculation with Cytocam-IDF camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Red blood cell velocity
Measuring red blood cell velocity by using the microcirculatory blood flow index by eye-balling, (0: no flow; 1: stop-and-go; 2: sluggish; 3: normal flow)
Measured: before start fluid bolus, 5 min, 10 min, 15 min, 20 min after the start of the fluid bolus
Secondary outcomes (1)
Change in Capillary vessel density
Offline analysis of the images made on known time points will provide a total vessel density change during the fluid bolus. Total vessel density: area of vessels divided by the total area of the image, mm/mm2.
Measured: before start fluid bolus, 5 min, 10 min, 15 min, 20 min after the start of the fluid bolus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startNov 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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 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
- NCT02675725
- Sponsor's protocol ID
- nWMO 128
- Status last verified
- Mar 2017
- First submitted
- 8 Jan 2016
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pranskunas A, Koopmans M, Koetsier PM, Pilvinis V, Boerma EC. Microcirculatory blood flow as a tool to select ICU patients eligible for fluid therapy. Intensive Care Med. 2013 Apr;39(4):612-9. doi: 10.1007/s00134-012-2793-8. Epub 2012 Dec 20.
PubMed 23263029Veenstra G, Ince C, Boerma EC. Direct markers of organ perfusion to guide fluid therapy: when to start, when to stop. Best Pract Res Clin Anaesthesiol. 2014 Sep;28(3):217-26. doi: 10.1016/j.bpa.2014.06.002. Epub 2014 Jul 15.
PubMed 25208957van Genderen ME, Klijn E, Lima A, de Jonge J, Sleeswijk Visser S, Voorbeijtel J, Bakker J, van Bommel J. Microvascular perfusion as a target for fluid resuscitation in experimental circulatory shock. Crit Care Med. 2014 Feb;42(2):e96-e105. doi: 10.1097/CCM.0b013e3182a63fbf.
PubMed 24158169Xu J, Ma L, Sun S, Lu X, Wu X, Li Z, Tang W. Fluid resuscitation guided by sublingual partial pressure of carbon dioxide during hemorrhagic shock in a porcine model. Shock. 2013 Apr;39(4):361-5. doi: 10.1097/SHK.0b013e31828936aa.
PubMed 23364438Ince C. The rationale for microcirculatory guided fluid therapy. Curr Opin Crit Care. 2014 Jun;20(3):301-8. doi: 10.1097/MCC.0000000000000091.
PubMed 24758985
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
- Kinetics of the Sublingual Microcirculation During the Treatment of a Postoperative Shock
- ClinicalTrials.gov ID
- NCT02675725
- Acronym / sponsor ID
- nWMO 128
- Conditions
- Surgery, Hypovolemic Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 5 Feb 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.
Fluid therapy is one of the cornerstones of the treatment of organ failure. The investigators assume that fluid bolus will increase the delivery of oxygen to the cells and resolve the shock.
The purpose of this study is to asses kinetics of the sublingual microcirculation in one place during a fluid bolus. It is expected that fluid therapy after normalization of the red blood cell flow velocity in the microcirculation will result in a decrease in capillary density through the formation of edema in the tissues. This can be considered to be the tipping of potentially beneficial to deleterious effects of fluid therapy.
After cardiac surgery patient will be transferred to the ICU for further stabilisation. Within specific indications the patient will receive a fluid bolus, these indications are hypotension, hyperlactataemia, tachycardia or decreased urine production. The fluid bolus will be 250 ml crystalloids in 15 minutes. The investigators will observe the sublingual microcirculation during this fluid bolus. To asses the red blood cell velocity and capillary vessel density on one spot during this fluid bolus.
Detailed description
Fluid therapy is one of the cornerstones of the treatment of organ failure. The investigators assume that a fluid bolus will increase the delivery of oxygen to the cells and resolve the shock. The evaluation of this treatment is done by clinical signs of organ perfusion en (little used) invasive hemodynamic monitoring. Previous research suggests that in-vivo microscopy of the microcirculation can be of importance to determine the type of shock and the reaction on treatment on tissue level.
Evaluation of the microcirculation was done by measuring red blood cell velocity on three different sites in the sublingual region. This was necessary in order to take heterogeneity into account, it was very hard to fix the camera on one spot during the observation period.
The purpose of this study is to asses kinetics of the sublingual microcirculation in one place during a fluid bolus. The great advantage is that the recordings before and after fluid therapy can be compared with each other as paired data, wherein the subject is its own control. By choosing a time interval that is long enough for the observation of the changes, but short enough for manual fixing of the camera, it seems possible to serve both purposes (15-30 minutes). This seems crucial now because both red blood cell flow as capillary density will be measured. It is expected that fluid therapy after normalization of the red blood cell flow velocity in the microcirculation will result in a decrease in capillary density through the formation of edema in the tissues. This can be considered to be the tipping of potentially beneficial to deleterious effects of fluid therapy.
After cardiac surgery patient will be transferred to the ICU for further stabilisation. Within specific indications the patient will receive a fluid bolus, these indications are hypotension, hyperlactataemia, tachycardia or decreased urine production. The fluid bolus will be 250 ml crystalloids in 15 minutes. The investigators will observe the sublingual microcirculation during this fluid bolus. To asses the red blood cell velocity and capillary vessel density on one spot during this fluid bolus.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post cardiac surgery | – | Device: Measurement of sublingual microcirculation with Cytocam-IDF cameraPatients after cardiac surgery with signs of decreased organ perfusion and the need of fluid therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postoperative cardiac surgery patients
Key inclusion criteria (2 listed)
- > 18 years old
- post-cardiac surgery and need for fluid therapy
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 |
|---|---|---|
| Measurement of sublingual microcirculation with Cytocam-IDF cameraThe normal treatment of a post-cardiac surgery patient is fluid bolus by indication. This indications are hypotension, hyperlactataemia, tachycardia or decreased urine production. This fluid bolus is 250 ml crystalloids in 15 minutes. When this fluid bolus will be given, the investigators will observe the sublingual microcirculation and measure the red blood cell velocity and total vessel density on one spot for 20 minutes. | Device | Post cardiac surgery |
Primary outcome
Change in Red blood cell velocity
Time frame: before start fluid bolus, 5 min, 10 min, 15 min, 20 min after the start of the fluid bolus
Measuring red blood cell velocity by using the microcirculatory blood flow index by eye-balling, (0: no flow; 1: stop-and-go; 2: sluggish; 3: normal flow)
1 secondary outcome
Change in Capillary vessel density
Time frame: before start fluid bolus, 5 min, 10 min, 15 min, 20 min after the start of the fluid bolus
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.
- Background: PubMed 23263029Pranskunas A, Koopmans M, Koetsier PM, Pilvinis V, Boerma EC. Microcirculatory blood flow as a tool to select ICU patients eligible for fluid therapy. Intensive Care Med. 2013 Apr;39(4):612-9. doi: 10.1007/s00134-012-2793-8. Epub 2012 Dec 20.
- Background: PubMed 25208957Veenstra G, Ince C, Boerma EC. Direct markers of organ perfusion to guide fluid therapy: when to start, when to stop. Best Pract Res Clin Anaesthesiol. 2014 Sep;28(3):217-26. doi: 10.1016/j.bpa.2014.06.002. Epub 2014 Jul 15.
- Background: PubMed 24158169van Genderen ME, Klijn E, Lima A, de Jonge J, Sleeswijk Visser S, Voorbeijtel J, Bakker J, van Bommel J. Microvascular perfusion as a target for fluid resuscitation in experimental circulatory shock. Crit Care Med. 2014 Feb;42(2):e96-e105. doi: 10.1097/CCM.0b013e3182a63fbf.
- Background: PubMed 23364438Xu J, Ma L, Sun S, Lu X, Wu X, Li Z, Tang W. Fluid resuscitation guided by sublingual partial pressure of carbon dioxide during hemorrhagic shock in a porcine model. Shock. 2013 Apr;39(4):361-5. doi: 10.1097/SHK.0b013e31828936aa.
- Background: PubMed 24758985Ince C. The rationale for microcirculatory guided fluid therapy. Curr Opin Crit Care. 2014 Jun;20(3):301-8. doi: 10.1097/MCC.0000000000000091.
- Individual participant dataSharing planned: No
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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 Surgery and Hypovolemic Shock, 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?
Change in Red blood cell velocity (time frame: before start fluid bolus, 5 min, 10 min, 15 min, 20 min after the start of the fluid bolus). 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 NCT02675725, which also lists 5 linked publications.
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.