- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01127152
Assessment of Automatic Relays by Intensive Basis Advantage Compared With Manual Relays, on the Hypotension Risks, During Noradrenalin Administration (ARIBA)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vendée
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La Roche sur Yon, Vendée, France, 85925
- CHD Vendée
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient > 18 years,
- Patient receiving only noradrenalin as catecholamine,
- Collection of patient's non-objection or his trustworthy person, if appropriate.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Automatic relays
Automatic relays of noradrenalin using intensive basis.
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Measure of arterial pressure will occur every five minutes during the thirty minutes before the relay and during the fifteen minutes after the relay.
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Active Comparator: Manual relays
Relays of noradrenalin using manual method
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Measure of arterial pressure will occur every five minutes during the thirty minutes before the relay and during the fifteen minutes after the relay.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay
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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
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during the fifteen minutes after the relay
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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
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every five minutes during the thirty minutes before the relay, during the fifteen minutes after the relay
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jean Reignier, MD, CHD Vendée
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHD 010-09
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