Circulatory FailureNCT02248025
Can Capillary Refill Time Variation During Passive Leg Raising Predict Fluid Responsiveness
An observational study of Circulatory Failure, run by Hopital Louis Pradel at 1 site in France.
Trial summary
Fluid responsiveness in a context of circulatory failure can be assessed by different way. Microcirculatory evaluation to assess fluid responsiveness could be interesting, but the available device are expensive and the analysis are delayed. Capillary refill time (CRT) is hampered by its variability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circulatory Failure
- What is being tested?
- Observational study: No special intervention will be made.
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to May 2017
- 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: Patient hospitalized in our intensive care unit who are in circulatory failure and for whom the intensivist as decided to administer a 500 ml crystalloid infusion.
Who may be able to join
- The patient is equipped with an arterial and a central venous catheter
- Capillary refill time is measurable.
- A cardiac output monitoring is available
- A 500 ml fluid load as been prescribed by the intensivist in charge.
- A circulatory failure is present defined as follow:
- Patient treated with inotropic or vasoconstrictive drugs
Show all 14Show fewer
- OR
- Patient presenting an hypotension defined by systolic arterial pressure less than 90 mmHg or mean arterial pressure less than 70 mmHg or a drop 40 mmHg in case of previous Hypertension.
- WITH
- tissue hypoperfusion defined by at least one of the following item:
- Lactate > 1 mmol/L
- Capillary refill time > 3 s
- Blotch
- Organ dysfunction due to the circulatory failure (oligo anuria, acute lung injury / acute respiratory distress syndrome, encephalopathy)
Who cannot join
- Pregnant woman
- Cardiogenic pulmonary edema
- Circulatory support : extracorporal life support / extracorporal membrane oxygenator, Thoratec, heart mate.
- Moribund patient
- Intra-abdominal hypertension
- Lower limb amputation
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Cardiologique Louis Pradel Service d'anesthésie réanimation
Bron, 69500
About this study
Official title: Can Capillary Refill Time Variation Induced by Passive Leg Raising Predict Capillary Refill Time Variation After a Fluid Load in Patients With Circulatory Failure.
Fluid responsiveness in a context of circulatory failure can be assessed by different way. Microcirculatory evaluation to assess fluid responsiveness could be interesting, but the available device are expensive and the analysis are delayed. Capillary refill time (CRT) is hampered by its variability. The investigators have developed a method to standardize the pressure, the length of compression and a computerized analysis to calculate the capillary refill time. This method enables accurate measure of CRT.
The investigators will study if CRT variation induced by a passive leg raising (PLR) can predict CRT after a 500 ml Fluid Load.
Read more
About thirty patients in circulatory failure with a continuous cardiac output monitoring for whom, the attending physician has decided a fluid load, will be included. hemodynamic parameters (arterial pressure, venous pressure, cardiac output), metabolic parameters (arterial and venous blood gas and lactate), microcirculatory parameters (assessed by sublingual video-microscopy) and capillary refill time measured on the thorax and on the gingival area will be recorded. Data collection will be made before and after a passive leg raising and after a 500 ml fluid load of crystalloids.
Patients will be aposteriori sorted in two groups: responders and non responders, defined by the reduction of CRT after the fluid load. The diagnosis ability of the CRT variation after PLR to predict in which group each patient is classified will be investigate and receiver operative characteristic curve will be built. These results will be compared to the metabolic response, the macrocirculatory response, and the microcirculatory response.
- Conditions
- Circulatory Failure
- Being tested
- Observational study: No special intervention will be made.
- Keywords
- Fluid responsiveness, capillary refill time, microcirculation, circulatory failure, passive leg raising
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study: No special intervention will be made.Other
No special intervention will be made, only data will be collected before, and after a passive leg raising and a fluid challenge decided and performed by the attending physician.
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary refill time response
A reduction of about 30% of the capillary refill time after a 500 ml fluid load will defined responders.
Evaluation of the diagnosis capacity of capillary refill time variation after passive leg raising to diagnose responders will be investigate.
Measured: The period of inclusion last 45 minutes, the outcome will be assessed at the end of the 500 ml fluid load 45 minutes after the inclusion.
Secondary outcomes (3)
Cardiac output response.
An increase of 15% of cardiac output after a 500 ml fluid load will define macrocirculatory responders.
Evaluation of the diagnosis capacity of capillary refill time after passive leg raising to diagnose macrocirculatory responders will be investigate.
Measured: The period of inclusion last 45 minutes, the outcome will be assessed at the end of the 500 ml fluid load 45 minutes after the inclusion.
Microcirculatory response
An increase of 15% of the proportion of perfused vessels or from 0.6 of the microcirculatory flow index assessed by videomicroscopy after a 500 ml fluid load will define microcirculatory responders.
Evaluation of the diagnosis capacity of capillary refill time variation after passive leg raising to diagnose microcirculatory responders will be investigate.
Measured: The period of inclusion last 45 minutes, the outcome will be assessed at the end of the 500 ml fluid load 45 minutes after the inclusion.
Metabolic response
An increase of 15% Oxygen consumption after a 500 ml fluid load will define metabolic responders.
Evaluation of the diagnosis capacity of capillary refill time to diagnose metabolic responders after passive leg raising will be investigate.
Measured: The period of inclusion last 45 minutes, the outcome will be assessed at the end of the 500 ml fluid load 45 minutes after the inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2017
- Study completionMay 2017
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 Circulatory FailureStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Louis Pradel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Jacquet-Lagrèze, Hopital Louis Pradel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248025
- Sponsor's protocol ID
- EudraCT/ANSM: 2014-A01034-43
- Status last verified
- May 2017
- First submitted
- 13 Sep 2014
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jacquet-Lagreze M, Bouhamri N, Portran P, Schweizer R, Baudin F, Lilot M, Fornier W, Fellahi JL. Capillary refill time variation induced by passive leg raising predicts capillary refill time response to volume expansion. Crit Care. 2019 Aug 16;23(1):281. doi: 10.1186/s13054-019-2560-0.
PubMed 31420052
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Capillary Refill Time Variation Induced by Passive Leg Raising Predict Capillary Refill Time Variation After a Fluid Load in Patients With Circulatory Failure.
- ClinicalTrials.gov ID
- NCT02248025
- Acronym / sponsor ID
- EudraCT/ANSM: 2014-A01034-43
- Conditions
- Circulatory Failure
- Keywords
- Fluid responsiveness, capillary refill time, microcirculation, circulatory failure, passive leg raising
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hopital Louis PradelUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 25 Sep 2014 (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 responsiveness in a context of circulatory failure can be assessed by different way. Microcirculatory evaluation to assess fluid responsiveness could be interesting, but the available device are expensive and the analysis are delayed. Capillary refill time (CRT) is hampered by its variability. The investigators have developed a method to standardize the pressure, the length of compression and a computerized analysis to calculate the capillary refill time. This method enables accurate measure of CRT.
The investigators will study if CRT variation induced by a passive leg raising (PLR) can predict CRT after a 500 ml Fluid Load.
About thirty patients in circulatory failure with a continuous cardiac output monitoring for whom, the attending physician has decided a fluid load, will be included. hemodynamic parameters (arterial pressure, venous pressure, cardiac output), metabolic parameters (arterial and venous blood gas and lactate), microcirculatory parameters (assessed by sublingual video-microscopy) and capillary refill time measured on the thorax and on the gingival area will be recorded. Data collection will be made before and after a passive leg raising and after a 500 ml fluid load of crystalloids.
Patients will be aposteriori sorted in two groups: responders and non responders, defined by the reduction of CRT after the fluid load. The diagnosis ability of the CRT variation after PLR to predict in which group each patient is classified will be investigate and receiver operative characteristic curve will be built. These results will be compared to the metabolic response, the macrocirculatory response, and the microcirculatory response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient hospitalized in our intensive care unit who are in circulatory failure and for whom the intensivist as decided to administer a 500 ml crystalloid infusion.
Key inclusion criteria (14 listed)
- The patient is equipped with an arterial and a central venous catheter
- Capillary refill time is measurable.
- A cardiac output monitoring is available
- A 500 ml fluid load as been prescribed by the intensivist in charge.
- A circulatory failure is present defined as follow:
Key exclusion criteria (6 listed)
- Pregnant woman
- Cardiogenic pulmonary edema
- Circulatory support : extracorporal life support / extracorporal membrane oxygenator, Thoratec, heart mate.
- Moribund patient
- Intra-abdominal hypertension
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 |
|---|---|---|
| Observational study: No special intervention will be made.No special intervention will be made, only data will be collected before, and after a passive leg raising and a fluid challenge decided and performed by the attending physician. | Other | – |
Primary outcome
Capillary refill time response
Time frame: The period of inclusion last 45 minutes, the outcome will be assessed at the end of the 500 ml fluid load 45 minutes after the inclusion.
A reduction of about 30% of the capillary refill time after a 500 ml fluid load will defined responders. Evaluation of the diagnosis capacity of capillary refill time variation after passive leg raising to diagnose responders will be investigate.
3 secondary outcomes
Cardiac output response.
Time frame: The period of inclusion last 45 minutes, the outcome will be assessed at the end of the 500 ml fluid load 45 minutes after the inclusion.
Microcirculatory response
Time frame: The period of inclusion last 45 minutes, the outcome will be assessed at the end of the 500 ml fluid load 45 minutes after the inclusion.
Metabolic response
Time frame: The period of inclusion last 45 minutes, the outcome will be assessed at the end of the 500 ml fluid load 45 minutes after the inclusion.
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 5 May 2017.
- Derived from this study: PubMed 31420052Jacquet-Lagreze M, Bouhamri N, Portran P, Schweizer R, Baudin F, Lilot M, Fornier W, Fellahi JL. Capillary refill time variation induced by passive leg raising predicts capillary refill time response to volume expansion. Crit Care. 2019 Aug 16;23(1):281. doi: 10.1186/s13054-019-2560-0.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Circulatory Failure, run by Hopital Louis Pradel 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 14 inclusion and 6 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 5 May 2017. 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 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?
Capillary refill time response (time frame: The period of inclusion last 45 minutes, the outcome will be assessed at the end of the 500 ml fluid load 45 minutes after the inclusion.). 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 NCT02248025, 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 5 May 2017.