Biochemical DysfunctionCAPIVEINNCT03890146
Concordance of Capillary Blood Biological Samples With Conventional Venousbiological Blood Samples.
An observational study of Biochemical Dysfunction, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biochemical Dysfunction
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2018to 21 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients hospitalized in the intensive care unit for any reason
Who may be able to join
- Patient over the age of 18
- Affiliate or beneficiary of a social security scheme
- Express consent to participate in the study
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concordance of Capillary Blood Biological Samples Analyzed in Delocalized Biology With Conventional Venous Biological Blood Samples Analyzed at the Biology Laboratory
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).
Read the 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.
- Conditions
- Biochemical Dysfunction
- Keywords
- intensive care, capillary sampling, veinous sampling, natremia, kalaemia, Chloremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| intensive care patients | patient hospitalised in intensive care unit veinous and capillary ponction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start20 Dec 2018
- Primary completion20 Dec 2020
- Study completion21 Dec 2020
Why it stopped: we submitted an amendment. The study was stopped because this amendment raised the complexity of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biochemical DysfunctionStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Nefeli Nasika, Principal investigator, Fonadtion Afolphe Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890146
- Sponsor's protocol ID
- 2018-A01880-55
- Acronym
- CAPIVEIN
- Status last verified
- Jan 2021
- First submitted
- 18 Feb 2019
- Last updated
- 29 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance of Capillary Blood Biological Samples Analyzed in Delocalized Biology With Conventional Venous Biological Blood Samples Analyzed at the Biology Laboratory
- ClinicalTrials.gov ID
- NCT03890146
- Acronym / sponsor ID
- CAPIVEIN / 2018-A01880-55
- Conditions
- Biochemical Dysfunction
- Keywords
- intensive care, capillary sampling, veinous sampling, natremia, kalaemia, Chloremia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: we submitted an amendment. The study was stopped because this amendment raised the complexity of the study.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intensive care patients | – | –patient hospitalised in intensive care unit veinous and capillary ponction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized in the intensive care unit for any reason
Key inclusion criteria (3 listed)
- Patient over the age of 18
- Affiliate or beneficiary of a social security scheme
- Express consent to participate in the study
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
Results and safety
The study was stopped early (reason given: we submitted an amendment. The study was stopped because this amendment raised the complexity of the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nefeli Nasika principal investigator
Fonadtion Afolphe Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biochemical Dysfunction, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: we submitted an amendment. The study was stopped because this amendment raised the complexity of the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concordance between capillary and veinous sampling for natremia result (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.