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Clinical Trials/NCT02248025
NCT02248025
Completed
Not Applicable

Can Capillary Refill Time Variation Induced by Passive Leg Raising Predict Capillary Refill Time Variation After a Fluid Load in Patients With Circulatory Failure.

Hopital Louis Pradel1 site in 1 country34 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Circulatory Failure
Sponsor
Hopital Louis Pradel
Enrollment
34
Locations
1
Primary Endpoint
Capillary refill time response
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
May 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matthias Jacquet-Lagrèze

Dr Matthias Jacquet-Lagèze

Hopital Louis Pradel

Eligibility 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
  • 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.
  • tissue hypoperfusion defined by at least one of the following item:
  • Lactate \> 1 mmol/L
  • Capillary refill time \> 3 s

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

Outcomes

Primary Outcomes

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

  • Metabolic response(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.)
  • Cardiac output response.(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(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.)

Study Sites (1)

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