Concordance of Capillary Blood Biological Samples With Conventional Venousbiological Blood Samples.

NCT03890146 | Terminated

• 1 other identifier: 2018-A01880-55
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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).

Conditions

Biochemical Dysfunction

Keywords

intensive care; capillary sampling; veinous sampling; natremia; kalaemia; Chloremia

Outcome Measures

Primary Outcomes (3)

• concordance between capillary and veinous sampling for natremia result

  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

  1 hour

• concordance between capillary and veinous sampling for kalemia result

  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

  1 hour

• concordance between capillary and veinous sampling for chloremiaresult

  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

  1 hour

Study Arms (1)

intensive care patients

patient hospitalised in intensive care unit veinous and capillary ponction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients hospitalized in the intensive care unit for any reason

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

France

Paris, 75019, France

Location

Study Officials

• Nefeli Nasika

  Fonadtion Afolphe Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: March 26, 2019
• Study Start: December 20, 2018
• Primary Completion: December 20, 2020
• Study Completion: December 21, 2020
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

FR (1)