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Concordance of Capillary Blood Biological Samples With Conventional Venousbiological Blood Samples. (CAPIVEIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890146
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:
The main objectives are to evaluate the concordance between the results of natremia, kalaemia and blood sugar levels obtained 1) by capillary puncture, analysed on a delocalized resuscitation machine GEM 4000 (Werfen) and 2) by venous sampling, analysed on the machine of the standard biology laboratory Gen. 2 COBAS (Roche).

Condition or disease
Biochemical Dysfunction

Detailed Description:

The completion of a biological test suits a succession of codified steps:

  • Medical prescription
  • The pre-analytic phase (preparation of the material, completion of the sample, transport of the sample and preparation of it)
  • The analytical phase
  • The post-analytic phase (validation of the result obtained and the dissemination of it to the prescriber, usually the clinician, who is then able to make a medical decision) This succession of steps involves, as part of a classical journey, many stakeholders (doctors, nurses, couriers, laboratory technicians, medical biologists) in different places.

Outsourced biology (care test point, POCT) refers to the analysis of biological samples outside the central laboratory. The sample is most often carried out, transported and analyzed by the same person on a machine near the patient or in the service and therefore in the absence of direct control of a specialized laboratory technician or a medical biologist, who remains however responsible for good practice, maintenance of the device and validity of the results.

The completion of biological examinations is regulated by differents Articles. The outsourced biology (ADBD) sampling analysis can be carried out in the hospital, in most departments, and also outside the hospital (pharmacies, city offices or even in the patient's own home). On portable devices, usually highly specialized, and these fixed allowing a greater diversity of tests.

Its development is booming with annual growth estimated in 2006 at 15.5% in the United States.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Concordance of Capillary Blood Biological Samples Analyzed in Delocalized Biology With Conventional Venous Biological Blood Samples Analyzed at the Biology Laboratory
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : December 20, 2020
Estimated Study Completion Date : December 21, 2020

Group/Cohort
intensive care patients
patient hospitalised in intensive care unit veinous and capillary ponction



Primary Outcome Measures :
  1. concordance between capillary and veinous sampling for natremia result [ Time Frame: 1 hour ]
    The concordance between the biological results obtained by capillary puncture analysed on the GEM 4000 resuscitation machine (Werfen), and the biological results by venous sampling analysed in the standard biology laboratory on the Gen. 2 COBAS machine (Roche) for natremia

  2. concordance between capillary and veinous sampling for kalemia result [ Time Frame: 1 hour ]
    The concordance between the biological results obtained by capillary puncture analysed on the GEM 4000 resuscitation machine (Werfen), and the biological results by venous sampling analysed in the standard biology laboratory on the Gen. 2 COBAS machine (Roche) for kalemia

  3. concordance between capillary and veinous sampling for chloremiaresult [ Time Frame: 1 hour ]
    The concordance between the biological results obtained by capillary puncture analysed on the GEM 4000 resuscitation machine (Werfen), and the biological results by venous sampling analysed in the standard biology laboratory on the Gen. 2 COBAS machine (Roche) for chloremia



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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
patients hospitalized in the intensive care unit for any reason
Criteria

Inclusion Criteria:

  • Patient over the age of 18
  • Affiliate or beneficiary of a social security scheme
  • Express consent to participate in the study

Exclusion Criteria:

  • Patient benefiting from a legal protection measure
  • Patient not communicating
  • Pregnant or breastfeeding woman
  • Peripheral edema (taking more than 5 Kg since entering the service)
  • Patient in shock (mean arterial pressure < 65 mmHg or continuous catecholamine administration)

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): NCT03890146


Contacts
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Contact: Amelie Yavchitz, MD, PhD 0148036454 ext 33 ayavchitz@for.paris

Locations
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France
France Recruiting
Paris, France, 75019
Contact: Stephane welschbillig, Dr    0148036987    swelschbillig@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: Nefeli Nasika Fonadtion Afolphe Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03890146    
Other Study ID Numbers: 2018-A01880-55
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
intensive care
capillary sampling
veinous sampling
natremia
kalaemia
Chloremia