Arterial HypertensionNCT04772599
Measurement of Noradrenaline Concentrations Using Different Dilution Methods
An observational study of Arterial Hypertension, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Norepinephrine is the vasopressor of choice for the treatment of peri-anesthetic arterial hypotension. The use of this drug at significantly lower concentrations (dilution factor between 40 and 200) than the commercial preparation is increasingly common in the operating room ("baby-noradrenaline"). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Hypertension
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2021to 1 Jul 2021
- 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
- Adult, Older adult
Study population: Employee of the University Hospitals of Strasbourg accepting to participate in the study
Who may be able to join
- Adult person,
- Employee of Strasbourg University Hospitals,
- Likely to have to prepare anesthesia drugs in the operating room (intern, hospital student, IADE, IADE student)
Who cannot join
- Subject's refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Strasbourg University Hospitals - Anesthesia-intensive care unit
Strasbourg, 67091
Thiên-Nga CHAMARAUX-TRAN, MD, 33 3 88 12 70 75, ThienNga.CHAMARAUX-TRAN@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, 33 3 88 11 66 90, said.chayer@chru-strasbourg.fr
About this study
Norepinephrine is the vasopressor of choice for the treatment of peri-anesthetic arterial hypotension. The use of this drug at significantly lower concentrations (dilution factor between 40 and 200) than the commercial preparation is increasingly common in the operating room ("baby-noradrenaline").
In addition, dilution errors are potentially serious for the patient (hypertensive peak) The preparation of precise dilutions is an important factor for the safe use of this medically In this study, the investigators wish to compare the dilution method of the protocol with another method of preparation (left to the free choice of the participant).
- Conditions
- Arterial Hypertension
- Keywords
- Noradrenaline, Norepinephrine, Concentration of noradrenaline, Vasopressor, Baby-noradrenaline, Dilution of Noradrenaline
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of noradrenaline concentrations using different dilution methods
Measurement methods:
- High performance liquid chromatography
- Measurement of the concentration of noradrenaline in the biochemical laboratory of the University Hospitals of Strasbourg
Measured: 1 hour after the preparation of the noradrenaline solutions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start21 Feb 2021
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772599
- Sponsor's protocol ID
- 7632
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Noradrenaline Concentrations Using Different Dilution Methods
- ClinicalTrials.gov ID
- NCT04772599
- Acronym / sponsor ID
- 7632
- Conditions
- Arterial Hypertension
- Keywords
- Noradrenaline, Norepinephrine, Concentration of noradrenaline, Vasopressor, Baby-noradrenaline, Dilution of Noradrenaline
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 21 Feb 2021 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 26 Feb 2021 (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.
Norepinephrine is the vasopressor of choice for the treatment of peri-anesthetic arterial hypotension. The use of this drug at significantly lower concentrations (dilution factor between 40 and 200) than the commercial preparation is increasingly common in the operating room ("baby-noradrenaline").
In addition, dilution errors are potentially serious for the patient (hypertensive peak) The preparation of precise dilutions is an important factor for the safe use of this medically In this study, the investigators wish to compare the dilution method of the protocol with another method of preparation (left to the free choice of the participant).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Employee of the University Hospitals of Strasbourg accepting to participate in the study
Key inclusion criteria (3 listed)
- Adult person,
- Employee of Strasbourg University Hospitals,
- Likely to have to prepare anesthesia drugs in the operating room (intern, hospital student, IADE, IADE student)
Key exclusion criteria (1 listed)
- Subject's refusal to participate in the study
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
Measurement of noradrenaline concentrations using different dilution methods
Time frame: 1 hour after the preparation of the noradrenaline solutions
Measurement methods: * High performance liquid chromatography * Measurement of the concentration of noradrenaline in the biochemical laboratory of the University Hospitals of Strasbourg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 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.
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 Arterial Hypertension, run by University Hospital, Strasbourg, France 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 1 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: status not confirmed, as of the sponsor's last update on 26 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thiên-Nga CHAMARAUX-TRAN, MD (33 3 88 12 70 75, ThienNga.CHAMARAUX-TRAN@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of noradrenaline concentrations using different dilution methods (time frame: 1 hour after the preparation of the noradrenaline solutions). 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 26 Feb 2021.