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Can Capillary Refill Time Variation During Passive Leg Raising Predict Fluid Responsiveness

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ClinicalTrials.gov Identifier: NCT02248025
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Matthias Jacquet-Lagrèze, Hopital Louis Pradel

Brief 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. 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.


Condition or disease Intervention/treatment
Circulatory Failure Other: Observational study: No special intervention will be made.

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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : September 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock


Intervention Details:
  • Other: 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.


Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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. ]

    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.


  2. 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. ]

    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.


  3. 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. ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

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)

Exclusion Criteria:

  • Pregnant woman
  • Cardiogenic pulmonary edema
  • Circulatory support : extracorporal life support / extracorporal membrane oxygenator, Thoratec, heart mate.
  • Moribund patient
  • Intra-abdominal hypertension
  • Lower limb amputation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248025


Locations
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France
Hôpital Cardiologique Louis Pradel Service d'anesthésie réanimation
Bron, France, 69500
Sponsors and Collaborators
Hopital Louis Pradel
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Matthias Jacquet-Lagrèze, Dr Matthias Jacquet-Lagèze, Hopital Louis Pradel
ClinicalTrials.gov Identifier: NCT02248025    
Other Study ID Numbers: EudraCT/ANSM: 2014-A01034-43
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Keywords provided by Matthias Jacquet-Lagrèze, Hopital Louis Pradel:
Fluid responsiveness
capillary refill time
microcirculation
circulatory failure
passive leg raising
Additional relevant MeSH terms:
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Shock
Pathologic Processes