SurgeryFCNCT04559178
Fluid Challenges and Microcirculation
An observational study of Surgery, run by Erasme University Hospital at 1 site in France.
Trial summary
The goal of this prospective observational study is to assess the impact of fluid challenge administration on macro and microcirculation in patients situated in the gray zone during a high risk abdominal surgery Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Surgery
- What is being tested?
- Fluid challenge
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2021to 30 Aug 2021
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients scheduled for a high-risk abdominal surgery and equipped with a minimally uncalibrated pulse contour analysis monitoring device as part of their anesthetic care. All patients will have the hemodynamic monintoring to assess macrocirculation and sublingual microcirculation.
Who may be able to join
- Patients undergoing a high-risk abdominal surgery
- Patients equipped with a minimally invasive cardiac output monitoring device in order to optimize fluid administration
Who cannot join
- Atrial fibrillation
- Ejection fraction <40%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Intraoperative Fluid Challenges Administration on Macro and Microcirculation in Patients Undergoing High-risk Abdominal Surgery and Situated in the Gray Zone of Pulse Pressure Variation
The goal of this prospective observational study is to assess the impact of fluid challenge administration on macro and microcirculation in patients situated in the gray zone during a high risk abdominal surgery
Read the detailed description
Fluid optimization is a key goal in anesthesia. It allows to titrate fluid bolus based on flow variables or dynamic parameters of fluid responsiveness (pulse pressure variation (PPV) or stroke volume variation (SVV)).
When PPV or SVV is above 13%, the patient will usually respond to a bolus of fluid while when PPV or SVV is below 9%, the patient will normally not respond to it. Between 9% and 13%, it is a gray zone where the effect of a fluid bolus is uncertain.
The overall goal of fluid bolus administration is of course to optimize macrocirculation (stroke volume and cardiac output) but also (and probably more importantly) end organ tissue perfusion. However, regional tissue perfusion is not widely monitored during surgery. However, we do have some monitoring tools to assess microcirculation at the bedside.
Investigation of microcirculation in addition to macro circulation may allow clinicians to know if a patient situated in the gray zone may or not increase microcirculation variables while macrocirculation variables are well known to be of little value to predict fluid responsiveness.
The goal of this study is to assess microcirculation variables in patients situated in the gray zone (PPV between 9%-13%), and to assess macro and microcirculation responses to a standardized fluid challenge of 4 ml/kg of a balanced crystalloid solution.
- Conditions
- Surgery
- Being tested
- Fluid challenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid challengeOther
fluid challenge administration when patient is in the gray zone
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular flow index
Comparison of this index before and after the fluid challenge
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start25 Jan 2021
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Why it stopped: too difficult to measure sublingual microcirculation continuously during a fluid challenge
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Joosten, MD PhD, Erasme University Hospital
- Investigators
- Alexandre JOOSTEN, MD PhD, Study director, ERASMEAlexandra Colesnicenco, MD, Principal investigator, ERASME
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559178
- Sponsor's protocol ID
- P2020/338 / B4062020000092
- Acronym
- FC
- Status last verified
- Sep 2022
- First submitted
- 16 Sep 2020
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intraoperative Fluid Challenges Administration on Macro and Microcirculation in Patients Undergoing High-risk Abdominal Surgery and Situated in the Gray Zone of Pulse Pressure Variation
- ClinicalTrials.gov ID
- NCT04559178
- Acronym / sponsor ID
- FC / P2020/338 / B4062020000092
- Conditions
- Surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: too difficult to measure sublingual microcirculation continuously during a fluid challenge
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 22 Sep 2020 (actual)
- 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.
The goal of this prospective observational study is to assess the impact of fluid challenge administration on macro and microcirculation in patients situated in the gray zone during a high risk abdominal surgery
Detailed description
Fluid optimization is a key goal in anesthesia. It allows to titrate fluid bolus based on flow variables or dynamic parameters of fluid responsiveness (pulse pressure variation (PPV) or stroke volume variation (SVV)).
When PPV or SVV is above 13%, the patient will usually respond to a bolus of fluid while when PPV or SVV is below 9%, the patient will normally not respond to it. Between 9% and 13%, it is a gray zone where the effect of a fluid bolus is uncertain.
The overall goal of fluid bolus administration is of course to optimize macrocirculation (stroke volume and cardiac output) but also (and probably more importantly) end organ tissue perfusion. However, regional tissue perfusion is not widely monitored during surgery. However, we do have some monitoring tools to assess microcirculation at the bedside.
Investigation of microcirculation in addition to macro circulation may allow clinicians to know if a patient situated in the gray zone may or not increase microcirculation variables while macrocirculation variables are well known to be of little value to predict fluid responsiveness.
The goal of this study is to assess microcirculation variables in patients situated in the gray zone (PPV between 9%-13%), and to assess macro and microcirculation responses to a standardized fluid challenge of 4 ml/kg of a balanced crystalloid solution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for a high-risk abdominal surgery and equipped with a minimally uncalibrated pulse contour analysis monitoring device as part of their anesthetic care. All patients will have the hemodynamic monintoring to assess macrocirculation and sublingual microcirculation.
Key inclusion criteria (2 listed)
- Patients undergoing a high-risk abdominal surgery
- Patients equipped with a minimally invasive cardiac output monitoring device in order to optimize fluid administration
Key exclusion criteria (2 listed)
- Atrial fibrillation
- Ejection fraction <40%
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 |
|---|---|---|
| Fluid challengefluid challenge administration when patient is in the gray zone | Other | – |
Primary outcome
Microvascular flow index
Time frame: day 0
Comparison of this index before and after the fluid challenge
Results and safety
The study was stopped early (reason given: too difficult to measure sublingual microcirculation continuously during a fluid challenge). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
Alexandre JOOSTEN, MD PhD study director
ERASME
Alexandra Colesnicenco, MD principal investigator
ERASME
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, run by Erasme University Hospital at 1 site in France.
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: stopped early, as of the sponsor's last update on 21 Sep 2022. 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 France. 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 was stopped early (reason given: too difficult to measure sublingual microcirculation continuously during a fluid challenge). Results are not available in the source record.
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?
Microvascular flow index (time frame: day 0). 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 21 Sep 2022.