HypotensionARIBANCT01127152
Assessment of Automatic Relays by Intensive Basis Advantage Compared With Manual Relays, on the Hypotension Risks, During Noradrenalin Administration
A study testing Measure of arterial pressure in people with Hypotension, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial summary
Circulatory failures are the main cause of admissions in the intensive care unit. It is recommended to prescribe to these patients an intravenous injection of catecholamine to correct this dysfunction and to keep an hemodynamic stability. Electric pumps are used to administrate a continuous flow of drugs to patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension
- What is being tested?
- Measure of arterial pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Apr 2011
- Phase
- Interventional
- 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
Who may be able to join
- Patient > 18 years,
- Patient receiving only noradrenalin as catecholamine,
- Collection of patient's non-objection or his trustworthy person, if appropriate.
Who cannot join
- Pregnant or breast feeding patient,
- Patient receiving an other treatment on the catecholamine way,
- No affiliation at a social security,
- Refusal of patient's trustworthy person or parent, if the patient is unable to give his non-objection.
- Refusal of patient's participation when he is conscious,
- Subjects deprived of liberty, under guardianship, hospitalized in a health facility or social or hospitalized without their consent,
- Patients with secreting tumor, kind pheochromocytoma ou carcinoid tumor.
Trial locations and contacts
1 site in 1 country.
About this study
Circulatory failures are the main cause of admissions in the intensive care unit. It is recommended to prescribe to these patients an intravenous injection of catecholamine to correct this dysfunction and to keep an hemodynamic stability. Electric pumps are used to administrate a continuous flow of drugs to patient. When a syringe of drugs ends, it is replaced by a full syringe, it is named "relay". This change may cause a flow interruption and hypotension.
In the intensive care unit at departmental hospital (CHD) Vendee, the manual relays used in common practice will cause hemodynamic instabilities : hypotensions in 20% cases. Since 4 years, new devices are also used to make the relays. It is "smart pumps" allowing to manage automated the drug delays. This new method allows to not interrupt the drug flow. It could reduce the occurence of hypotension. A 50% decrease of relative number of hypotension will show that the use of automatic method is the most sure medical strategy.
Our study want to compare manual and automatic method watching the variations of medium arterial pressure (MAP) during the fifteen minutes after the relay compared to baseline (MAP before the relay). Noradrenalin is the catecholamine most administrated so we choose to study only the relay for this drug.
- Conditions
- Hypotension
- Being tested
- Measure of arterial pressure
- Keywords
- Noradrenalin relays, Automatic relays, Manual relays, Hypotension, Intensive care unit
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of arterial pressureProcedure or surgery
Measure of arterial pressure will occur every five minutes during the thirty minutes before the relay and during the fifteen minutes after the relay.
| Study group | Role | What they receive |
|---|---|---|
| Automatic relays | Active comparator | Automatic relays of noradrenalin using intensive basis. Receives: Procedure: Measure of arterial pressure |
| Manual relays | Active comparator | Relays of noradrenalin using manual method Receives: Procedure: Measure of arterial pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension occurence defined as a decrease of 20% of the medium arterial pressure(MAP) between the baseline (MAP before the relay) and the minimal MAP in the fifteen minutes after the relay.
Measured: every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay
Secondary outcomes (3)
Number of relays where the medium arterial pressure (MAP) is decreased by 10% compared to baseline
Measured: every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay
Number of relays where the medium arterial pressure (MAP) is inferior to 50 millimeter of mercury (mmHg)
Measured: during the fifteen minutes after the relay
Number of hypotension in patients whose dose of noradrenalin is > 0,5 gamma/kg/min
Measured: every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startJun 2009
- Primary completionFeb 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Reignier, MD, Principal investigator, CHD Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127152
- Sponsor's protocol ID
- CHD 010-09
- Acronym
- ARIBA
- Status last verified
- Nov 2025
- First submitted
- 18 May 2010
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Greau E, Lascarrou JB, Le Thuaut A, Maquigneau N, Alcourt Y, Coutolleau A, Rousseau C, Erragne V, Reignier J. Automatic versus manual changeovers of norepinephrine infusion pumps in critically ill adults: a prospective controlled study. Ann Intensive Care. 2015 Dec;5(1):40. doi: 10.1186/s13613-015-0083-7. Epub 2015 Nov 14.
PubMed 26577132
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Automatic Relays by Intensive Basis Advantage Compared With Manual Relays, on the Hypotension Risks, During Noradrenalin Administration
- ClinicalTrials.gov ID
- NCT01127152
- Acronym / sponsor ID
- ARIBA / CHD 010-09
- Conditions
- Hypotension
- Keywords
- Noradrenalin relays, Automatic relays, Manual relays, Hypotension, Intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 20 May 2010 (estimated)
- 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.
Circulatory failures are the main cause of admissions in the intensive care unit. It is recommended to prescribe to these patients an intravenous injection of catecholamine to correct this dysfunction and to keep an hemodynamic stability. Electric pumps are used to administrate a continuous flow of drugs to patient. When a syringe of drugs ends, it is replaced by a full syringe, it is named "relay". This change may cause a flow interruption and hypotension.
In the intensive care unit at departmental hospital (CHD) Vendee, the manual relays used in common practice will cause hemodynamic instabilities : hypotensions in 20% cases. Since 4 years, new devices are also used to make the relays. It is "smart pumps" allowing to manage automated the drug delays. This new method allows to not interrupt the drug flow. It could reduce the occurence of hypotension. A 50% decrease of relative number of hypotension will show that the use of automatic method is the most sure medical strategy.
Our study want to compare manual and automatic method watching the variations of medium arterial pressure (MAP) during the fifteen minutes after the relay compared to baseline (MAP before the relay). Noradrenalin is the catecholamine most administrated so we choose to study only the relay for this drug.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automatic relays | Active comparator | Procedure: Measure of arterial pressureAutomatic relays of noradrenalin using intensive basis. |
| Manual relays | Active comparator | Procedure: Measure of arterial pressureRelays of noradrenalin using manual method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient > 18 years,
- Patient receiving only noradrenalin as catecholamine,
- Collection of patient's non-objection or his trustworthy person, if appropriate.
Key exclusion criteria (7 listed)
- Pregnant or breast feeding patient,
- Patient receiving an other treatment on the catecholamine way,
- No affiliation at a social security,
- Refusal of patient's trustworthy person or parent, if the patient is unable to give his non-objection.
- Refusal of patient's participation when he is conscious,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure of arterial pressureMeasure of arterial pressure will occur every five minutes during the thirty minutes before the relay and during the fifteen minutes after the relay. | Procedure or surgery | Automatic relays, Manual relays |
Primary outcome
Hypotension occurence defined as a decrease of 20% of the medium arterial pressure(MAP) between the baseline (MAP before the relay) and the minimal MAP in the fifteen minutes after the relay.
Time frame: every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay
3 secondary outcomes
Number of relays where the medium arterial pressure (MAP) is decreased by 10% compared to baseline
Time frame: every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay
Number of relays where the medium arterial pressure (MAP) is inferior to 50 millimeter of mercury (mmHg)
Time frame: during the fifteen minutes after the relay
Number of hypotension in patients whose dose of noradrenalin is > 0,5 gamma/kg/min
Time frame: every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 26577132Greau E, Lascarrou JB, Le Thuaut A, Maquigneau N, Alcourt Y, Coutolleau A, Rousseau C, Erragne V, Reignier J. Automatic versus manual changeovers of norepinephrine infusion pumps in critically ill adults: a prospective controlled study. Ann Intensive Care. 2015 Dec;5(1):40. doi: 10.1186/s13613-015-0083-7. Epub 2015 Nov 14.
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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.
Jean Reignier, MD principal investigator
CHD Vendée
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measure of arterial pressure in people with Hypotension, run by Centre Hospitalier Departemental Vendee 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 7 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: finished, as of the sponsor's last update on 17 Nov 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hypotension occurence defined as a decrease of 20% of the medium arterial pressure(MAP) between the baseline (MAP before the relay) and the minimal MAP in the fifteen minutes after the relay. (time frame: every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01127152, which also lists 1 linked publication.
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 17 Nov 2025.