- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02248025
Can Capillary Refill Time Variation During Passive Leg Raising Predict Fluid Responsiveness
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bron, France, 69500
- Hôpital Cardiologique Louis Pradel Service d'anesthésie réanimation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
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.
|
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. |
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.
|
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. |
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.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EudraCT/ANSM: 2014-A01034-43
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Circulatory Failure
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingAcute Circulatory Failure
-
Hospices Civils de LyonCompleted
-
Centre Hospitalier ArrasCompletedAcute Circulatory FailureFrance
-
Hospices Civils de LyonCompleted
-
University Hospital, BordeauxCompletedCirculatory Failure (Shock)France
-
University Hospital, AngersRecruitingShock | Hemodynamic Monitoring | Acute Circulatory FailureFrance
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingExtracorporeal Membrane Oxygenation Complication | Cerebral Circulatory FailureNetherlands
-
Centre Hospitalier Universitaire de NīmesCompleted
-
Association pour le Développement et l'Organisation...CompletedAcute Circulatory Failure
-
Nantes University HospitalUnknownAcute Circulatory FailureFrance
Clinical Trials on Observational study: No special intervention will be made.
-
Hopital Louis PradelCompletedCirculatory FailureFrance
-
Firat UniversityUnknownQuality of Life | Knee Osteoarthritis | KinesiophobiaTurkey
-
University of ZurichWithdrawnTherapy-resistant Hypertension and Sleep ApneaSwitzerland
-
Centre Hospitalier Universitaire VaudoisThe Novartis FoundationRecruiting
-
The University of Texas Health Science Center,...CompletedWound InfectionUnited States
-
Chinese University of Hong KongHospital Authority of Hong Kong (Bradbury Hospice)Completed
-
Alba Health ABUppsala University; Universiteit Antwerpen; Copenhagen Studies on Asthma in ChildhoodEnrolling by invitationHealthy | Microbial ColonizationSweden
-
Kansas City Heart Rhythm Research FoundationRecruitingAtrial FibrillationUnited States
-
University Hospitals of Derby and Burton NHS Foundation...Not yet recruitingHaemodialysis | End Stage Renal Disease on DialysisUnited Kingdom