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Completed

NCT Number: NCT02248025

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Cardiologique Louis Pradel Service d'anesthésie réanimation

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hopital Louis Pradel

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 25, 2014
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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